2012 pipeline report launched in Washington: HIV, HCV, TB, PEP, cure and vaccine research.
On July 21- 2012 HIV i-Base (U.K.) and Treatment Action Group (TAG) (U.S.) released their new comprehensive "2012 Pipeline Report"
The report is ready to view at the new website launched today by "TAG"
For the HCV community, there is a particular article in the report written by Tracy Swan and Karyn Kaplan you won't want to miss;
Hepatitis C Drug Development Goes from Pony Ride to Rocket Launch.
The in depth report includes some of the following topics; HCV drug resistance, DAA drug-drug interactions, nucleosides and nucleotide polymerase inhibitors, HCV protease inhibitors, the next generation of drugs, HCV quad therapy, SVR-4 ,SVR-12, interferon free therapy, ABT-450/r, ACH-1625, BI 201335, bms-650032, bms-790052, Danoprevir, genotypes 1-4, GS-7977 Formally/PSI-7977, GS-9256, Lambda, MK-7009, TMC435 and much more....
The 2012 Pipeline Report: HIV, Hepatitis C Virus (HCV), and Tuberculosis (TB) Drugs, Diagnostics, Vaccines, and Preventive Technologies in Development by Polly Clayden, Simon Collins, Colleen Daniels, Nathan Geffen, Mark Harrington, Richard Jefferys, Coco Jervis, Karyn Kaplan, Erica Lessem, and Tracy Swan is available online at:
http://www.treatmentactiongroup.org/pipeline-report/2012
and as an interactive web report at:
http://www.pipelinereport.org.
Showing posts with label ACH-1625. Show all posts
Showing posts with label ACH-1625. Show all posts
Friday, July 13, 2012
Monday, April 23, 2012
EASL-Achillion Clarifies End of Treatment Data From Phase 2a Trial With ACH-1625 Based Regimen in Hepatitis C
NEW HAVEN, Conn., Apr 23, 2012 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. /quotes/zigman/100395/quotes/nls/achn ACHN -0.24% today provided clarification with respect to end of treatment (EOT) data from segment 2 of its Phase 2a trial of ACH-1625 that was presented during the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona, Spain on April 21, 2012.
In this study, 58 patients were randomized to receive ACH-1625 at a once daily dose of 200 mg, 400 mg, or 800 mg in combination with pegylated interferon and ribavirin (P/R) for twelve weeks. At of the time of the poster presentation, a total of 22 patients had completed 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R as per response guided treatment (RGT.) All (22/22, or 100%) patients had undetectable levels of HCV RNA at the end of the 24 weeks of treatment.
EOT was defined in the EASL poster presentation as any patient who returned for an EOT visit, which also included those patients who withdrew from the study prior to week 12. The additional EOT data is defined as patients who achieved extended rapid virological response (eRVR) and received a total of 24 weeks of therapy consisting of 12 week of ACH-1625 plus P/R followed by 12 weeks of P/R alone.
The rapid virological response (RVR) at week 4, cEVR at week 12 and EOT results for all patients returning for an EOT visit (30 patients) presented in the poster, as well as detailed results for patients who received a total of 24 weeks of therapy consisting of 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R alone, are provided in the table below.
Michael Kishbauch, President and Chief Executive Officer, commented, "We are providing these results as we recognized that some of the data was not clear at our poster session at EASL. We remain both happy and encouraged with the continued potency of ACH-1625, including the 100% response for all patients who completed a full 24 week regimen, and we hope that this clarification provides additional transparency with respect to the ACH-1625 data." About ACH-1625 ACH-1625 is a Phase 2 pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has demonstrated rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM. ACH-1625 has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV. About HCV The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration. About Achillion Pharmaceuticals Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to the potency, safety, tolerability, effectiveness and other characteristics of ACH-1625. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings. In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law. This news release was distributed by GlobeNewswire, www.globenewswire.com SOURCE: Achillion Pharmaceuticals, Inc.
In this study, 58 patients were randomized to receive ACH-1625 at a once daily dose of 200 mg, 400 mg, or 800 mg in combination with pegylated interferon and ribavirin (P/R) for twelve weeks. At of the time of the poster presentation, a total of 22 patients had completed 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R as per response guided treatment (RGT.) All (22/22, or 100%) patients had undetectable levels of HCV RNA at the end of the 24 weeks of treatment.
EOT was defined in the EASL poster presentation as any patient who returned for an EOT visit, which also included those patients who withdrew from the study prior to week 12. The additional EOT data is defined as patients who achieved extended rapid virological response (eRVR) and received a total of 24 weeks of therapy consisting of 12 week of ACH-1625 plus P/R followed by 12 weeks of P/R alone.
The rapid virological response (RVR) at week 4, cEVR at week 12 and EOT results for all patients returning for an EOT visit (30 patients) presented in the poster, as well as detailed results for patients who received a total of 24 weeks of therapy consisting of 12 weeks of ACH-1625 plus P/R followed by 12 weeks of P/R alone, are provided in the table below.
| ACH-1625 | |||
| Segment 2: 12-week treatment duration assessments | 200 mg n=19 | 400 mg n=20 | 800 mg n=19 |
| RVR (HCV RNA < 25 IU/mL week 4), % (n) | 79% (15/19) | 89% (16/18) ** | 90% (17/19) |
| cEVR (undetectable week 12), % (n) | 100% (18/18) * | 94% (15/16) ** | 100% (19/19) |
| EOT Visit (including patients who withdrew) (undetectable) *** % (n) | 86% (6/7) | 69% (9/13) | 100% (10/10) |
| Reasons for discontinuation include: *200 mg 1 patient withdrew for unrelated AEs at Week 5. **400 mg 1 patient withdrew consent at Week 9, 1 patient moved at Week 2, each were undetectable at the time of withdrawal; 2 patients withdrew for unrelated AEs, one before Week 4 and one before Week 12. ***EOT denominator includes only patients who returned for their end of treatment visit. | |||
| Patients who achieved eRVR and received 12 weeks of ACH-1625 and P/R followed by 12 weeks of P/R | 200 mg | 400 mg | 800 mg |
| Undetectable, % (n) | 100% (5/5) | 100% (7/7) † | 100% (10/10) † |
| † Two patients in both the 400 mg and 800 mg dose groups had week 4 RVR (HCV RNA < 25) with remaining patients below lower limit of detection. | |||
Michael Kishbauch, President and Chief Executive Officer, commented, "We are providing these results as we recognized that some of the data was not clear at our poster session at EASL. We remain both happy and encouraged with the continued potency of ACH-1625, including the 100% response for all patients who completed a full 24 week regimen, and we hope that this clarification provides additional transparency with respect to the ACH-1625 data." About ACH-1625 ACH-1625 is a Phase 2 pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has demonstrated rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM. ACH-1625 has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV. About HCV The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration. About Achillion Pharmaceuticals Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to the potency, safety, tolerability, effectiveness and other characteristics of ACH-1625. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings. In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law. This news release was distributed by GlobeNewswire, www.globenewswire.com SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
Saturday, April 21, 2012
EASL-100% Complete EVR From Phase 2 Trial With ACH-1625 Based Regimen in Hepatitis C
April 21, 2012
Achillion Announces 94 - 100% Complete EVR From Phase 2 Trial With ACH-1625 Based Regimen in Hepatitis C
Posters Detailing ACH-1625, ACH-3102 and ACH-2928 Presented at the International Liver Congress(TM) 2012
NEW HAVEN, Conn., April 21, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that in the second segment of its Phase 2a trial of ACH-1625, 94 to 100 percent of patients with treatment naïve genotype 1 chronic hepatitis C virus (HCV) achieved a complete early virologic response (cEVR) after 12 weeks of treatment with ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin (P/R). ACH-1625 in combination with P/R for up to 12 weeks was safe and well tolerated and produced high viral response rates regardless of dose level or IL28B genotype status.
Results from this trial were presented during the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona, Spain from April 18 — 22, 2012. Additional posters detailing Achillion's NS5A inhibitor program, including ACH-2928 and ACH-3102, were also presented during EASL
Michael D. Kishbauch, President and Chief Executive Officer of Achillion commented, "We are extremely pleased with the safety and efficacy that ACH-1625 has achieved in this Phase 2 clinical trial as well as the impressive resistance profile this compound has shown to date. As we finalize this Phase 2 trial and report on SVR later this year, we are now focused on initiating our all-oral program for the treatment of HCV. With the recent submission of an IND for ACH-3102, our second-generation NS5A inhibitor, we look forward to initiating its Phase 1 program this quarter and rapidly advancing toward a therapeutic, interferon-free combination trial evaluating ACH-1625 plus ACH-3102 during the fourth quarter of this year."
ACH-1625: Phase 2 protease inhibitor for the treatment of HCV
In Segment 2 of this Phase 2a trial, a total of 58 subjects with HCV were enrolled, randomized and stratified by IL28B genotype, including CT and TT, which is a marker of a patient's responsiveness to interferon, to receive one of three doses of once-daily ACH-1625 (200 mg, 400 mg or 800 mg) in combination with P/R for 12 weeks of therapy.
Of the patients enrolled, the majority had HCV genotype 1a (n=35 (60%)), with remaining patients having HCV genotype 1b (n=20) or genotype 1 (n=3). Approximately 71% of the patients were IL28B genotype CT/TT, the more difficult to treat mutation, 64% were male and 17% were African American. No viral breakthroughs were observed during treatment. Results demonstrated rapid virological response (RVR) at week 4, cEVR and end of treatment (EOT) responses for patients returning for EOT visit to date as follows:
Safety results from both segments of the trial were similar to those observed and previously reported during clinical trials of ACH-1625. Most reported adverse events (AEs) in patients receiving ACH-1625 were classified as mild to moderate and were transient. The most common AEs were consistent with pegylated interferon alfa-2a and ribavirin treatment. During 12 weeks of co-administration of ACH-1625 plus P/R, there was one reported serious adverse event (SAE) that was deemed unrelated to ACH-1625. There was no difference noted between dose groups for either the incidence or severity of observed adverse events.
"We were pleased to note that across the dose groups and regardless of IL28B status, nearly all patients treated through 12 weeks achieved cEVR. The clinical potency, unique pharmacokinetic profile, and barrier to resistance for ACH-1625 appear to provide very effective antiviral coverage for all of these genotype 1 patients," commented Dr. Elizabeth A. Olek, Chief Medical Officer of Achillion. "With the continued on-treatment viral suppression and impressive initial end of treatment response rates, we look forward to reporting out the sustained viral response rates for these patients later in the year."
In a separate poster presentation, the clinical virology of NS3 variants from patients enrolled in Segment 1 of the Phase 2a clinical trial evaluating multiple ascending doses of ACH-1625 in combination with P/R was presented. Sequencing of baseline to post-treatment samples revealed that there were no mutations at loci 155, 156, or 168 of NS3 protease, which represent common mutations that may confer resistance to protease inhibitors. To date, no viral breakthrough has been observed during monotherapy with ACH-1625 or with ACH-1625-based treatment regimens suggesting that the potency of ACH-1625 is sufficient to inhibit the growth of the most frequently observed resistant mutants.
Additional NS5A Inhibitor Posters Presented at EASL
- Preclinical characteristics of ACH-3102: A novel HCV NS5A inhibitor with improved potency against genotype 1a virus and variants resistance to 1st generation of NS5A inhibitors (abstract A845. Y. Zhao, et al.)
- Novel NS5A inhibitor ACH-2928 phase 1 results in HCV GT-1 patients (abstract 1211. B. Vince, et al.)
About ACH-1625
ACH-1625 is a Phase 2 pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has demonstrated rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM. ACH-1625 has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potency, safety, tolerability, effectiveness and other characteristics of ACH-1625; and Achillion's expectations regarding timing for the completion and reporting of additional results of Phase 2 clinical trials of ACH-1625 and the commencement of a Phase 1 clinical trials of ACH-1625 plus ACH-3102. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
» Return to Achillion Investor Relations
Achillion Announces 94 - 100% Complete EVR From Phase 2 Trial With ACH-1625 Based Regimen in Hepatitis C
Posters Detailing ACH-1625, ACH-3102 and ACH-2928 Presented at the International Liver Congress(TM) 2012
NEW HAVEN, Conn., April 21, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that in the second segment of its Phase 2a trial of ACH-1625, 94 to 100 percent of patients with treatment naïve genotype 1 chronic hepatitis C virus (HCV) achieved a complete early virologic response (cEVR) after 12 weeks of treatment with ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin (P/R). ACH-1625 in combination with P/R for up to 12 weeks was safe and well tolerated and produced high viral response rates regardless of dose level or IL28B genotype status.
Results from this trial were presented during the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona, Spain from April 18 — 22, 2012. Additional posters detailing Achillion's NS5A inhibitor program, including ACH-2928 and ACH-3102, were also presented during EASL
Michael D. Kishbauch, President and Chief Executive Officer of Achillion commented, "We are extremely pleased with the safety and efficacy that ACH-1625 has achieved in this Phase 2 clinical trial as well as the impressive resistance profile this compound has shown to date. As we finalize this Phase 2 trial and report on SVR later this year, we are now focused on initiating our all-oral program for the treatment of HCV. With the recent submission of an IND for ACH-3102, our second-generation NS5A inhibitor, we look forward to initiating its Phase 1 program this quarter and rapidly advancing toward a therapeutic, interferon-free combination trial evaluating ACH-1625 plus ACH-3102 during the fourth quarter of this year."
ACH-1625: Phase 2 protease inhibitor for the treatment of HCV
In Segment 2 of this Phase 2a trial, a total of 58 subjects with HCV were enrolled, randomized and stratified by IL28B genotype, including CT and TT, which is a marker of a patient's responsiveness to interferon, to receive one of three doses of once-daily ACH-1625 (200 mg, 400 mg or 800 mg) in combination with P/R for 12 weeks of therapy.
Of the patients enrolled, the majority had HCV genotype 1a (n=35 (60%)), with remaining patients having HCV genotype 1b (n=20) or genotype 1 (n=3). Approximately 71% of the patients were IL28B genotype CT/TT, the more difficult to treat mutation, 64% were male and 17% were African American. No viral breakthroughs were observed during treatment. Results demonstrated rapid virological response (RVR) at week 4, cEVR and end of treatment (EOT) responses for patients returning for EOT visit to date as follows:
| ACH-1625 | |||
| 200 mg | 400 mg | 800 mg | |
| Segment 2: 12-week treatment duration assessments | n=19 | n=20 | n=19 |
| RVR (HCV RNA < 25 IU/mL week 4), % (n) | 79% (15/19) | 89% (16/18) ** | 90% (17/19) |
| cEVR (undetectable week 12), | 100% (18/18) * | 94% (15/16) ** | 100% (19/19) |
| % (n) | |||
| EOT Response (undetectable) *** % (n) | 86% (6/7) | 69% (9/13) | 100% (10/10) |
| Reasons for discontinuation include: *200 mg 1 patient withdrew for unrelated AEs at Week 5. **400 mg 1 patient withdrew consent at Week 9, 1 patient moved at Week 2, each were undetectable at the time of withdrawal; 2 patients withdrew for unrelated AEs, one before Week 4 and one before Week 12. ***EOT denominator includes only patients who returned for their end of treatment visit | |||
"We were pleased to note that across the dose groups and regardless of IL28B status, nearly all patients treated through 12 weeks achieved cEVR. The clinical potency, unique pharmacokinetic profile, and barrier to resistance for ACH-1625 appear to provide very effective antiviral coverage for all of these genotype 1 patients," commented Dr. Elizabeth A. Olek, Chief Medical Officer of Achillion. "With the continued on-treatment viral suppression and impressive initial end of treatment response rates, we look forward to reporting out the sustained viral response rates for these patients later in the year."
In a separate poster presentation, the clinical virology of NS3 variants from patients enrolled in Segment 1 of the Phase 2a clinical trial evaluating multiple ascending doses of ACH-1625 in combination with P/R was presented. Sequencing of baseline to post-treatment samples revealed that there were no mutations at loci 155, 156, or 168 of NS3 protease, which represent common mutations that may confer resistance to protease inhibitors. To date, no viral breakthrough has been observed during monotherapy with ACH-1625 or with ACH-1625-based treatment regimens suggesting that the potency of ACH-1625 is sufficient to inhibit the growth of the most frequently observed resistant mutants.
Additional NS5A Inhibitor Posters Presented at EASL
- Preclinical characteristics of ACH-3102: A novel HCV NS5A inhibitor with improved potency against genotype 1a virus and variants resistance to 1st generation of NS5A inhibitors (abstract A845. Y. Zhao, et al.)
- Novel NS5A inhibitor ACH-2928 phase 1 results in HCV GT-1 patients (abstract 1211. B. Vince, et al.)
About ACH-1625
ACH-1625 is a Phase 2 pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has demonstrated rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM. ACH-1625 has shown clinical antiviral activity against genotypes 1 and 3. Fast Track status was granted to ACH-1625 in 2012 for the treatment of chronic HCV.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including nearly 4 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potency, safety, tolerability, effectiveness and other characteristics of ACH-1625; and Achillion's expectations regarding timing for the completion and reporting of additional results of Phase 2 clinical trials of ACH-1625 and the commencement of a Phase 1 clinical trials of ACH-1625 plus ACH-3102. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
» Return to Achillion Investor Relations
Wednesday, April 4, 2012
EASL: ACH-1625 -Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Good Morning Folks,
April 4
EASL ABSTRACTS NOW READY TO VIEW
Click Here
.
Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
.
In The News
Idenix Pharmaceuticals Inc. and Achillion Pharmaceuticals Inc. will both present at the European Association for the Study of the Liver (EASL) meeting in Barcelona on April 18-22.
Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Brian Wilson
Source
Continue Reading...
April 4
EASL ABSTRACTS NOW READY TO VIEW
Click Here
.
Public
The abstracts will be available on the EASL website, http://www.easl.eu as of today.
.
In The News
Idenix Pharmaceuticals Inc. and Achillion Pharmaceuticals Inc. will both present at the European Association for the Study of the Liver (EASL) meeting in Barcelona on April 18-22.
Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Brian Wilson
Source
Achillion’s pipeline also includes one preclinical-stage drug being developed for bacterial infections, although the bulk of the company’s resources are being spent on HCV (hepatitis C virus). Achillion have five separate HCV drugs in various stages of development, most notable is ACH-1625 which is classified as a protease inhibitor.
The hepatitis C virus, in order to replicate, needs particular protease enzymes to construct new virions which allow the disease to continue to attack the body. ACH-1625 is an inhibitor of the HCV NS3 protease, which means this drug should prove effective if it can prevent this protein from functioning. The NS3 protein that is targeted by ACH-1625 has been studied extensively, and serves critical functions in the HCV infection process. All non-structural proteins with regards to HCV are processed by NS2 and NS3, and due to their necessary interaction, inhibition of NS3 should hypothetically be a nearly-insurmountable obstacle for HCV replication. As of now, ACH-1625 has passed Phase I trials which have validated its relative safety and lack of side-effects. Phase II trials will give further insight into the efficacy of the drug against viral replication by HCV.
ACH-2684 is a broader protease inhibitor being developed to suppress the natural variants of the hepatitis C virus by the same mechanism. According to the company, the compound is also potent against standard genotypes of HCV which means it could be just as (if not more) effective than inhibition of just the NS3 protein, although the company claims that it has actually been tailored to affect the NS3 protease. The efficacy of this broader ranged protease inhibitor is difficult to determine at this stage, since it has only proven potency in the “low pico-molar range” (an incredibly small volume), but the fact that it might target mutant strands of HCV makes it worthwhile.
The third drug in the pipeline that has begun its clinical trials is ACH-2928, which acts through another mechanism by inhibiting HCV NS5A. This protein actively antagonizes a cell’s response to a viral infection through RNA-binding, and research is being done to investigate its suspected role in genome replication. The second generation version of this, ACH-3102, is being developed with enhanced abilities to fight off resilient strains of HCV that would be less susceptible to ACH-2928.
ACH-1625 will be releasing results of its Phase IIa clinical trials on April 18-22, at the International Liver Conference being hosted in Barcelona. Shares have already rocketed up at the start of 2012, but there’s reason to believe that some early confirmation of ACH-1625′s efficacy in a larger sample size could be immensely beneficial for the stock. News may be slow after this since many fresh studies are being started this year, but investors may jump the gun if the data on this generation of protease inhibitors gives hope on stopping HCV.
Continue Reading...
Friday, February 17, 2012
ACH-1625 Discussed in Oral Presentation at 2012 Asian Pacific Liver Conference
February 16, 2012
Virology Profile Following Treatment With ACH-1625 Discussed in Oral Presentation at 2012 Asian Pacific Liver Conference
NEW HAVEN, Conn., Feb. 16, 2012 (GLOBE NEWSWIRE) --
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that novel preclinical and clinical virology data on ACH-1625, a Phase 2 pan-genotypic protease inhibitor, was presented in an oral presentation at the 2012 Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2012), February 16-19, 2012, in Taipei, Taiwan.
The oral presentation, "Characterization of Hepatitis C Virus Variants Detected in vitro and in vivo After Treatment with ACH-1625, a Potent HCV NS3 Protease Inhibitor," (Abstract PS01-05) was made by Mingjun Huang, Ph.D., Vice President of Virology at Achillion, during APASL 2012 on Friday, February 17.
The presentation discussed the viral resistant mutations identified in preclinical and Phase 1 clinical studies. The analyses showed that not only did wild type hepatitis C virus (HCV) profoundly decline following exposure to ACH-1625, but also that no rebound of the virus carrying the most common resistant mutations, specifically those at loci 155, 156, 168, was observed in genotype 1 HCV patients. Furthermore, the majority of resistant mutants displayed reduced replication fitness in vitro and remained sensitive to other classes of direct-acting antiviral agents.
"These data reveal a very interesting phenomenon in which following 5-day ACH-1625 monotherapy there was persistent suppression of HCV viral load observed even in the presence of pre-existing resistant variants," commented Dr. Huang. "These ad hoc study data, along with previously announced Phase 2 clinical results demonstrating significant suppression of HCV viral RNA with 100% cEVR, and an emerging virology profile that suggests a potential to suppress resistant variants, lead us to believe that ACH-1625 is well positioned to become an integral part of the future treatment of HCV in combination with other oral direct acting antiviral agents including our own NS5A inhibitors."
"As ACH-1625 continues to deliver what we believe to be a best-in-class profile for the treatment of HCV, these data further highlight the attributes of this potent, combinable, and to date very well-tolerated compound for the treatment of potentially all types of chronic hepatitis C infection," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "We look forward to completing the current Phase 2 clinical trial of ACH-1625 and initiating all-oral, interferon-free combination studies with ACH-1625 later this year."
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit http://www.globenewswire.com/newsroom/ctr?d=246111&l=6&a=www.achillion.com&u=http%3A%2F%2Fwww.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the potency, safety, tolerability, effectiveness, combinability and other characteristics of ACH-1625; Achillion's expectations regarding timing for the commencement and completion of clinical trials of ACH-1625; the potential for ACH-1625 to play an important role in the future treatment of HCV in combination with other oral direct acting antiviral agents; and the potential for ACH-1625 to be a best-in-class HCV treatment. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of ACH-1625 and its other drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com» Return to Achillion Investor Relations
Tuesday, January 17, 2012
Video-FDA Grants Fast-Track Status to Achillion’s Hepatitis C Drug
Jan 17, 2012
- 4:14 -
Achillion CFO Mary Kay Fenton on the benefits of the company’s new hepatitis C drug.
Press Release - Jan 4
Achillion hepatitis drug gets faster FDA review
AP) NEW HAVEN, Conn. — A chronic hepatitis c treatment being developed by from Achillion Pharmaceuticals received fast track designation, allowing for a quicker review by regulators.
Achillion said Wednesday the treatment, labeled ACH-1625, is in mid-stage clinical testing. The designation allows drug developers to submit their applications to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once.
It also allows for more frequent interaction with regulators and a possible priority review.
Achillion Pharmaceuticals Inc., based in New Haven, Conn., said the drug received the designation due in part to its once-daily dosing and its potential to offer improved safety and tolerability compared to the current standard of care.
Hepatitis C treatments represent a big opportunity for drugmakers. The virus can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. Analysts expect the market for those treatments to expand in the coming years.
Other companies developing potential drugs include Pharmasset Inc. which is being acquired by Gilead Sciences Inc. Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales.
Press Release - Jan 4
Achillion hepatitis drug gets faster FDA review
AP) NEW HAVEN, Conn. — A chronic hepatitis c treatment being developed by from Achillion Pharmaceuticals received fast track designation, allowing for a quicker review by regulators.
Achillion said Wednesday the treatment, labeled ACH-1625, is in mid-stage clinical testing. The designation allows drug developers to submit their applications to the Food and Drug Administration piece by piece instead of having to file all the paperwork at once.
It also allows for more frequent interaction with regulators and a possible priority review.
Achillion Pharmaceuticals Inc., based in New Haven, Conn., said the drug received the designation due in part to its once-daily dosing and its potential to offer improved safety and tolerability compared to the current standard of care.
Hepatitis C treatments represent a big opportunity for drugmakers. The virus can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. Analysts expect the market for those treatments to expand in the coming years.
Other companies developing potential drugs include Pharmasset Inc. which is being acquired by Gilead Sciences Inc. Earlier this year, the FDA approved two pills that offered the first new breakthrough treatments for the liver disease in 20 years. The Vertex Pharmaceuticals Inc. hepatitis C pill Incivek rang up about $420 million in this year's third quarter. Another pill, Merck & Co.'s Victrelis had $31 million in sales.
Wednesday, January 4, 2012
ACH-1625 Protease Inhibitor Receives Fast Track For The Treatment Of HCV
ACH-1625 Receives Fast Track Designation for the Treatment of Chronic Hepatitis C
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
NEW HAVEN, Conn., Jan. 4, 2012 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, announced today the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-1625 for the treatment of chronic hepatitis C virus (HCV). ACH-1625 is a once-daily protease inhibitor with broad genotypic coverage against HCV that was discovered by Achillion and is currently being evaluated in a Phase 2 clinical trial.
Fast Track designation was granted to ACH-1625 for its potential to provide:
- Improved safety and tolerability as compared to the current standard of care;
- Convenient once-daily dosing;
- Broader genotypic coverage of HCV;
- An improved drug-drug interaction profile with greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation; and
- Development in a once-daily interferon-free oral combination.
"We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor's attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year."
Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases which demonstrate the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical development time and review period.
About ACH-1625
ACH-1625 is a HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM.
In the first segment of a Phase 2a clinical study, treatment-naïve genotype 1 HCV patients received doses of 200 mg, 400 mg, or 800 mg of ACH-1625 in combination with pegylated interferon and ribavirin (SOC) and achieved a rapid viral response (RVR) of 75 — 81% compared to an RVR of 20% for patients receiving SOC only. ACH-1625 was well tolerated at all doses with no serious adverse events reported and adverse events which were reported as mild to moderate and transient. The second segment of this Phase 2a, randomized, double-blind trial is evaluating the safety, tolerability and antiviral activity of once daily ACH-1625, at doses of 200 mg, 400 mg or 800 mg, in combination with SOC for 12 weeks of dosing. The primary endpoint for this trial is complete early virological response (cEVR). Following 12 weeks of therapy, patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and be eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.
About HCV
The hepatitis C virus infects the liver and is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80 percent of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and an injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to the potency, safety and tolerability over currently-approved therapies, increased effectiveness and other characteristics of ACH-1625, Achillion's expectations regarding timing for the commencement, completion and reporting of results from clinical trials of Achillion's protease inhibitors, and the potential benefits of Fast Track designation for ACH-1625. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things: Achillion's ability to: replicate in later clinical trials positive results found in earlier stage clinical trials of ACH-1625 and its other product candidates; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
Monday, October 3, 2011
AASLD-Achillion Presents Updated Data on Multiple Compounds
Updates;
AASLD Nov 2011
AASLD Nov 2011
Achillion to Present Updated Clinical and Preclinical Data on Multiple Compounds at AASLD 2011
NEW HAVEN, Conn., Oct. 3, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals,Inc. (Nasdaq:ACHN), a leader in the discovery and develop ment of small molecule drugs to combat the most challenging infectious diseases, today announced that four abstracts on HCV compounds discovered and developed by Achillion were accepted for presentation at the 62nd Annual Meeting of the American Association for the Study of Liver Disease (AASLD) to be held November 4-8, 2011 in San Francisco, CA.
During the congress, a poster presentation detailing Phase 2 segment 1 clinical trial results for ACH-1625, a once-daily protease inhibitor, will report updated 28-day safety and efficacy results for ACH-1625 administered in combination with pegylated-interferon and ribavirin for the treatment of treatment naïve genotype 1 HCV. Preclinical data on ACH-2684, a once-daily pan-genotypic protease inhibitor, as well as novel preclinical data for Achillion's second generation NS5A inhibitor compounds, will be reported during poster presentations at AASLD.
The Achillion data presentations at AASLD are as follows:
| Date/Time | Presentation Title |
| November 5 2:00 — 7:30 p.m. | Pharmacokinetic Modeling of ACH-2684, a Hepatoselective Phase I Pan-Genotypic HCV NS3 Protease Inhibitor: Predictions and Correlation with Human Pharmacokinetics |
| November 5 2:00 — 7:30 p.m. | Novel Hepatitis C Virus NS5A Inhibitors with Improved Potency against Genotype -1a Replicons and Replicons Carrying Mutations Associated with Viral Resistance to 1st Generation NS5A Inhibitors |
| November 5 2:00 — 7:30 p.m. | Combinatory Effect of Direct Anti-HCV Agents on Antiviral Efficacy and Viral Resistance in Genotype-1a and -1b Replicons as well as Replicons Carrying NS3 Protease or NS5A Protein from Patient Isolates |
| November 7 8:00 a.m. — 5:30 p.m. | High Rapid Virologic Response(RVR) with ACH-1625 Daily Dosing plus PegIFN-alpha 2a/RBV in a 28-day Phase 2a Trial |
"As we look toward the upcoming AASLD meeting in November, we continue to work toward our goal of delivering on a number of significant milestones for Achillion. Our focus remains on reporting top-line Phase 2 12-week EVR results for ACH-1625 in combination with pegylated-interferon and ribavirin for the treatment of genotype 1 treatment-naïve HCV, and realizing proof-of-concept Phase 1 results for both ACH-2684 against HCV genotypes 1 and 3, and ACH-2928 against genotypes 1a and 1b, all near the end of this year," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion.
Abstracts can be accessed at the AASLD website at http://www.aasld.org.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of Achillion's NS5A inhibitors, which may not be duplicated in clinical studies, and Achillion's expectations regarding results, timing and duration of clinical trials and reporting of results from clinical trials of ACH-1625, ACH-2684 and Achillion's NS5A inhibitors, including ACH-2928. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are Achillion's ability to complete the development of its drug candidates under the timelines it anticipates in current and future clinical trials; to obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; to establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agreements with appropriate third-parties; and to raise the capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (646) 229-5178
christin.miller@ogilvypr.com
Wednesday, June 22, 2011
Achillion Initiates 12-Wk Dosing in Phase 2 Trial of ACH-1625 For Hepatitis C
NEW HAVEN, Conn., Jun 22, 2011 (GlobeNewswire via COMTEX) --
Achillion Pharmaceuticals, Inc. /quotes/zigman/100395/quotes/nls/achn ACHN -0.83% today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.
The clinical trial has advanced into the second segment of a Phase 2a, randomized, double-blind trial evaluating the safety, tolerability and antiviral activity of oral ACH-1625 in combination with standard of care (SOC) consisting of pegylated interferon alfa-2a and ribavirin. Patients will be randomized to receive once daily doses of 200 mg, 400 mg or 800 mg of ACH-1625 in combination with SOC for 12 weeks of dosing. Patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.
The trial will take place in the United States and Europe and is designed to enroll approximately 60 HCV-infected patients. The 12-week complete early virologic response (cEVR) trial results are anticipated to be announced in the fourth quarter of 2011.
"Initiating the second segment of this Phase 2 clinical trial allows us to build upon the robust RVR results we observed with ACH-1625, and to further augment the safety and efficacy database by taking the opportunity to study multiple doses of ACH-1625," commented Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "We expect that the results will provide important insight to benchmark the activity of our once-daily protease inhibitor and we look forward to reporting cEVR results by the end of this year."
"This next study segment with ACH-1625 is yet another important milestone achieved for this potentially best-in-class protease inhibitor and for Achillion's broader HCV pipeline," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "It should be recalled that, very recently, we announced the start of Phase 1 on Achillion's high-potency, pan-genotypic protease inhibitor, ACH-2684, and with the upcoming start of Phase 1 on our first NS5A inhibitor, ACH-2928, Achillion remains poised to deliver on a number of clinical milestones over the next few quarters that we believe will significantly enhance our overall position within the important and promising HCV market."
About ACH-1625
ACH-1625 is a HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. ACH-1625 has rapid and extensive partitioning to the liver, as well as high liver/plasma ratios. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 of approximately 1nM.
In the first segment of a Phase 2a clinical study, HCV-infected patients receiving doses of 200 mg, 400 mg, or 800 mg of ACH-1625 in combination with SOC achieved a rapid viral response of 75 -- 81% compared to an RVR of 20% for patients receiving SOC only. ACH-1625 was well tolerated at all doses with no serious adverse events reported and adverse events which were reported as mild to moderate and transient.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-1625, which may not be duplicated in future cohorts at different doses or in future clinical studies of longer duration, and Achillion's expectations regarding timing and duration of other clinical trials. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks and uncertainties that Achillion faces are described in greater detail in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings. All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
This news release was distributed by GlobeNewswire, http://www.globenewswire.com/
SOURCE: Achillion Pharmaceuticals, Inc.
Wednesday, March 30, 2011
Achillion ACH-1625 hepatitis drug shows promise in mid-stage trial
UPDATE 2-Achillion hepatitis drug shows promise in mid-stage trial
Wed Mar 30, 2011 8:52am EDT
* Says 75-81 pct patients showed anitviral activity
* Plans to start a trial testing ACH-1625, ACH-2928 in 2012
* Shares up 4 pct in pre-market trade (Adds background, updates share movement)
March 30 (Reuters) - Achillion Pharmaceuticals Inc said its experimental lead drug to treat chronic hepatitis C infection showed strong antiviral activity in a mid-stage trial, sending its shares up 4 percent in pre-market trade.
The company said 75-81 percent patients who took ACH-1625 in combination with current standard of care (SoC)-- Roche Holding AG's Pegasys and generic antiviral pill ribavirin -- showed potent antiviral activity in the fourth week.
The drug showed a promising safety and tolerability profile, Achillion said.
Worldwide, more than 170 million people are suffering from HCV and the American Association of Liver Disease estimates that up to 80 percent of individuals become chronically infected following exposure to the virus.
The mid-stage trial involving 64 patients tested three doses of ACH-1625 given once daily or a dummy drug in combination with current SoC treatment for four weeks.
"We look forward to selecting two of these doses and beginning the second segment of the trial, dosing ACH-1625 with SoC over 12 weeks," Chief Medical Officer Elizabeth Olek said.
The company expects to report complete early virology response data from this trial by the end of this year.
Also, it expects to start a trial evaluating ACH-1625 in combination with its other HCV drug ACH-2928 in 2012.
Shares of the company were up 30 cents at $7.35 in pre-market trade. They closed at $7.05 on Tuesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Don Sebastian; Editing by Maju Samuel)
http://www.reuters.com/article/2011/03/30/achillion-idUSL3E7EU1OT20110330?feedType=RSS&feedName=governmentFilingsNews
Wed Mar 30, 2011 8:52am EDT
* Says 75-81 pct patients showed anitviral activity
* Plans to start a trial testing ACH-1625, ACH-2928 in 2012
* Shares up 4 pct in pre-market trade (Adds background, updates share movement)
March 30 (Reuters) - Achillion Pharmaceuticals Inc said its experimental lead drug to treat chronic hepatitis C infection showed strong antiviral activity in a mid-stage trial, sending its shares up 4 percent in pre-market trade.
The company said 75-81 percent patients who took ACH-1625 in combination with current standard of care (SoC)-- Roche Holding AG's Pegasys and generic antiviral pill ribavirin -- showed potent antiviral activity in the fourth week.
The drug showed a promising safety and tolerability profile, Achillion said.
Worldwide, more than 170 million people are suffering from HCV and the American Association of Liver Disease estimates that up to 80 percent of individuals become chronically infected following exposure to the virus.
The mid-stage trial involving 64 patients tested three doses of ACH-1625 given once daily or a dummy drug in combination with current SoC treatment for four weeks.
"We look forward to selecting two of these doses and beginning the second segment of the trial, dosing ACH-1625 with SoC over 12 weeks," Chief Medical Officer Elizabeth Olek said.
The company expects to report complete early virology response data from this trial by the end of this year.
Also, it expects to start a trial evaluating ACH-1625 in combination with its other HCV drug ACH-2928 in 2012.
Shares of the company were up 30 cents at $7.35 in pre-market trade. They closed at $7.05 on Tuesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Don Sebastian; Editing by Maju Samuel)
http://www.reuters.com/article/2011/03/30/achillion-idUSL3E7EU1OT20110330?feedType=RSS&feedName=governmentFilingsNews
Sunday, March 20, 2011
Hepatitis; U.S. Patent granted for ACH-1625 and Related Protease Inhibitors
Achillion Granted U.S. Patent for ACH-1625 and Related Protease Inhibitors
NEW HAVEN, Conn., — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the U.S. Patent & Trademark Office has granted Achillion U.S. Patent No. 7,906,619, covering composition-of-matter and method of use claims for ACH-1625 and structurally related compounds. ACH-1625 is Achillion’s phase 2 protease inhibitor to treat hepatitis C virus (HCV) infection. This new patent, entitled “4-amino-4-oxobutanoyl peptides as inhibitors of viral replication,” provides a patent term until 2029.
“This key patent grant provides a cornerstone for Achillion’s intellectual property portfolio for ACH-1625 and a number of structurally related compounds, molecules that were discovered and synthesized here by Achillion’s discovery team,” commented Michael D. Kishbauch, Achillion’s President and Chief Executive Officer. “We believe this strengthening of our patent estate, combined with our expected upcoming pipeline milestones, including 4-week rapid viral response, or RVR, results from an ongoing phase 2 clinical trial of ACH-1625, and the advancement of ACH-2684 and ACH-2928 into phase 1 clinical development during the first half of 2011, will make this a transformational year for Achillion.”
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion’s proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease – hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to Achillion’s expectations regarding the results of clinical trials and the timing and duration of clinical trials. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion’s ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
All forward-looking statements reflect Achillion’s expectations only as of the date of this release and should not be relied upon as reflecting Achillion’s views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
NEW HAVEN, Conn., — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the U.S. Patent & Trademark Office has granted Achillion U.S. Patent No. 7,906,619, covering composition-of-matter and method of use claims for ACH-1625 and structurally related compounds. ACH-1625 is Achillion’s phase 2 protease inhibitor to treat hepatitis C virus (HCV) infection. This new patent, entitled “4-amino-4-oxobutanoyl peptides as inhibitors of viral replication,” provides a patent term until 2029.
“This key patent grant provides a cornerstone for Achillion’s intellectual property portfolio for ACH-1625 and a number of structurally related compounds, molecules that were discovered and synthesized here by Achillion’s discovery team,” commented Michael D. Kishbauch, Achillion’s President and Chief Executive Officer. “We believe this strengthening of our patent estate, combined with our expected upcoming pipeline milestones, including 4-week rapid viral response, or RVR, results from an ongoing phase 2 clinical trial of ACH-1625, and the advancement of ACH-2684 and ACH-2928 into phase 1 clinical development during the first half of 2011, will make this a transformational year for Achillion.”
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion’s proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease – hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to Achillion’s expectations regarding the results of clinical trials and the timing and duration of clinical trials. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion’s ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.
All forward-looking statements reflect Achillion’s expectations only as of the date of this release and should not be relied upon as reflecting Achillion’s views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Thursday, December 30, 2010
2011: ACH-1625 Shown to significantly reduce viral load
What's Next for Achillion Pharma?
Achillion stock (ACHN) has been flat all year, underperforming the biotech indices as well as its peers in the Hepatitis C drug development community. The stock began to leap a couple days after the company announced that data from ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011. It has since climbed from $2.73 to close at $4.00 Wednesday, a 47% increase since the December 6th announcement.
So why all the excitement? Achillion had been making headlines all year; it promoted two new drugs into the clinic, began Phase II trials for lead candidate ACH-1625, presented at multiple industry conferences, and raised a total of $71.4 million in stock offerings.
The reason, I believe, is a key phrasing in the press release, “data from ongoing clinical studies of ACH-1625” was to be presented at the conference. There is only one ongoing study: A 144 patient Phase IIa randomized, double blinded trial of ACH-1625 in combination with ribavirin and peg-interferon alpha. The trial begins with a dose-ranging 28 day phase that will be evaluated to determine the optimal dose for the final 12 week treatment phase.
The company had initially targeted March 2011 for release of the first set of results. Having the ability to move the release date up to February speaks well for trial enrollment. This data will provide the first look at how Achillion’s lead candidate performs in a larger setting and importantly, in combination with current standard of care. ACH-1625 has already been shown to significantly reduce viral loads in patients by 3 to 4.25 log10 and maintain a sustained viral response even after therapy has stopped. It has also been shown to be safe up to 2000mg/day, a level far above the highest dose tested in this Phase IIa.
Pre-clinical studies show ACH-1625 to be additive-synergistic to ribavirin and peg-interferon alpha; this study will be a first look at how well those studies translate in the clinic. Although 28 days is still short, the multiple active drug doses as well as a placebo control will allow investigators to gauge in detail the effectiveness of ACH-1625 in this combination. In any case, a full profile of the compound and its potential as part of this three-drug regimen will be in known by the end of 2011. There’s a lot riding on this study.
Aside from its lead compound, Achillion also has a lineup of several other HCV antivirals in development. The once promising ACH-1095, an inhibitor of the NS4A protease is in Phase I. It was originally developed in collaboration with Gilead (GILD), but its rights have since been handed back to the company- though Gilead still retains the ability to opt in at a later stage in the compound’s development.
Early this year in January, a second NS3 protease inhibitor, ACH-2684, was nominated to enter clinical development. It's interesting that Achillion is developing additional NS3 inhibitors considering there are so many out there. This one is being positioned as more potent and effective against commonly seen viral mutants. It will enter Phase I trials in 2011.
The NS5A inhibitor, ACH-2928, was nominated in mid-year. It is also set to initiate Phase I testing in 2011. ACH-2928 is one of the few NS5A inhibitors currently in development. The most prominent competitor compound is BMS-790052 from Bristol Myers Squibb (BMY), currently in Phase II and looking pretty good. Both of these compounds have similarly high potencies in vitro.
Achillion also has some work in antibiotics and HBV, but they are not a major focus. The goal now is to push forward with its HCV pipeline. 2011 will be pivotal for the company as data comes in from its lead project. Funds raised during the year will allow it to complete both portions of the Phase II trial and at the same time initiate two separate Phase I studies. It will be interesting to see how the company chooses to proceed from there.
http://seekingalpha.com/article/244145-what-s-next-for-achillion-pharma
Achillion stock (ACHN) has been flat all year, underperforming the biotech indices as well as its peers in the Hepatitis C drug development community. The stock began to leap a couple days after the company announced that data from ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011. It has since climbed from $2.73 to close at $4.00 Wednesday, a 47% increase since the December 6th announcement.
So why all the excitement? Achillion had been making headlines all year; it promoted two new drugs into the clinic, began Phase II trials for lead candidate ACH-1625, presented at multiple industry conferences, and raised a total of $71.4 million in stock offerings.
The reason, I believe, is a key phrasing in the press release, “data from ongoing clinical studies of ACH-1625” was to be presented at the conference. There is only one ongoing study: A 144 patient Phase IIa randomized, double blinded trial of ACH-1625 in combination with ribavirin and peg-interferon alpha. The trial begins with a dose-ranging 28 day phase that will be evaluated to determine the optimal dose for the final 12 week treatment phase.
The company had initially targeted March 2011 for release of the first set of results. Having the ability to move the release date up to February speaks well for trial enrollment. This data will provide the first look at how Achillion’s lead candidate performs in a larger setting and importantly, in combination with current standard of care. ACH-1625 has already been shown to significantly reduce viral loads in patients by 3 to 4.25 log10 and maintain a sustained viral response even after therapy has stopped. It has also been shown to be safe up to 2000mg/day, a level far above the highest dose tested in this Phase IIa.
Pre-clinical studies show ACH-1625 to be additive-synergistic to ribavirin and peg-interferon alpha; this study will be a first look at how well those studies translate in the clinic. Although 28 days is still short, the multiple active drug doses as well as a placebo control will allow investigators to gauge in detail the effectiveness of ACH-1625 in this combination. In any case, a full profile of the compound and its potential as part of this three-drug regimen will be in known by the end of 2011. There’s a lot riding on this study.
Aside from its lead compound, Achillion also has a lineup of several other HCV antivirals in development. The once promising ACH-1095, an inhibitor of the NS4A protease is in Phase I. It was originally developed in collaboration with Gilead (GILD), but its rights have since been handed back to the company- though Gilead still retains the ability to opt in at a later stage in the compound’s development.
Early this year in January, a second NS3 protease inhibitor, ACH-2684, was nominated to enter clinical development. It's interesting that Achillion is developing additional NS3 inhibitors considering there are so many out there. This one is being positioned as more potent and effective against commonly seen viral mutants. It will enter Phase I trials in 2011.
The NS5A inhibitor, ACH-2928, was nominated in mid-year. It is also set to initiate Phase I testing in 2011. ACH-2928 is one of the few NS5A inhibitors currently in development. The most prominent competitor compound is BMS-790052 from Bristol Myers Squibb (BMY), currently in Phase II and looking pretty good. Both of these compounds have similarly high potencies in vitro.
Achillion also has some work in antibiotics and HBV, but they are not a major focus. The goal now is to push forward with its HCV pipeline. 2011 will be pivotal for the company as data comes in from its lead project. Funds raised during the year will allow it to complete both portions of the Phase II trial and at the same time initiate two separate Phase I studies. It will be interesting to see how the company chooses to proceed from there.
http://seekingalpha.com/article/244145-what-s-next-for-achillion-pharma
Monday, December 6, 2010
Hepatitis C: ACH-1625 To Be Presented at Asian Pacific Liver Conference
Achillion To Present Data From Studies Of ACH-1625 In Hepatitis C At Asian Pacific Liver Conference
NEW HAVEN, Conn., Dec. 6, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011 in Bangkok, Thailand.
ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The presentation, entitled "Viral Kinetics Modeling of Short-term Monotherapy Data of ACH-1625, an HCV Protease Inhibitor," will be presented by Dr. Atul Agarwal, Senior Director of Computational Chemistry of Achillion. (Abstract A-315-0024-00792.)
The presentation describes a mathematical analysis of HCV RNA data collected after oral administration of ACH-1625 in HCV genotype 1 infected subjects. This analysis shows rapid and near complete hepatitis C virus clearance following ACH-1625 administration at all dose levels tested. In addition, mathematical modeling of HCV viral kinetics provided information that allowed for subsequent dose selection for Phase II clinical development of ACH-1625.
"These data support and further demonstrate ACH-1625's robust antiviral activity," said Dr. Agarwal. "With clinical data that demonstrated reductions in viral RNA between 3-4.25 log10, these mathematical data quantitatively show the percentage of total virus cleared after five days of ACH-1625 monotherapy.
This data also identifies specific patient population characteristics."
"We are pleased to continue to put forward a large body of scientific and clinical data on ACH-1625," commented Michael D. Kishbauch, Chief Executive Officer of Achillion. "We look forward to completing the current Phase II clinical trial of ACH-1625 to further support its profile as a potential best-in-class protease inhibitor for the treatment of HCV."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies, HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
Continue reading........
For more information on Achillion Pharmaceuticals, please visit http://www.achillion.com/ or call 1-203-624-7000.
NEW HAVEN, Conn., Dec. 6, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that data from the Company's ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011 in Bangkok, Thailand.
ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The presentation, entitled "Viral Kinetics Modeling of Short-term Monotherapy Data of ACH-1625, an HCV Protease Inhibitor," will be presented by Dr. Atul Agarwal, Senior Director of Computational Chemistry of Achillion. (Abstract A-315-0024-00792.)
The presentation describes a mathematical analysis of HCV RNA data collected after oral administration of ACH-1625 in HCV genotype 1 infected subjects. This analysis shows rapid and near complete hepatitis C virus clearance following ACH-1625 administration at all dose levels tested. In addition, mathematical modeling of HCV viral kinetics provided information that allowed for subsequent dose selection for Phase II clinical development of ACH-1625.
"These data support and further demonstrate ACH-1625's robust antiviral activity," said Dr. Agarwal. "With clinical data that demonstrated reductions in viral RNA between 3-4.25 log10, these mathematical data quantitatively show the percentage of total virus cleared after five days of ACH-1625 monotherapy.
This data also identifies specific patient population characteristics."
"We are pleased to continue to put forward a large body of scientific and clinical data on ACH-1625," commented Michael D. Kishbauch, Chief Executive Officer of Achillion. "We look forward to completing the current Phase II clinical trial of ACH-1625 to further support its profile as a potential best-in-class protease inhibitor for the treatment of HCV."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies, HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
Continue reading........
For more information on Achillion Pharmaceuticals, please visit http://www.achillion.com/ or call 1-203-624-7000.
Saturday, October 9, 2010
ACH-1625 Achillion's HCV Pipeline Progresses
Achillion's HCV Pipeline Progresses
http://www.dailymarkets.com
Recently, Achillion Pharmaceuticals, Inc. (ACHN: 3.01 +0.05 +1.69%) announced that it has started dosing patients in a randomized, double-blind mid-stage study (n∼120) that will evaluate pipeline candidate ACH-1625. The candidate is being developed to treat patients infected with hepatitis C virus (HCV).
The placebo-controlled phase IIa study, to be conducted in the United States and Europe, will evaluate the safety, tolerability and antiviral activity of the HCV candidate as a combination therapy. Specifically, ACH-1625 (an oral candidate) will be evaluated in conjunction with pegylated interferon alfa-2a and ribavirin after 4 and 12 weeks of dosing in patients infected with chronic HCV genotype 1. While results from the 4 week study are expected in the first quarter of 2011, the 12 week study results are anticipated by the end of 2011.
ACH-1625, a HCV inhibitor molecule which has fared well in earlier studies, is an important candidate for Achillion. The candidate, on successful development and commercialization, will target the highly lucrative HCV market with a huge unmet need.
HCV infection is estimated to affect more than 170 million people across the globe. Moreover, according to estimates released by the American Association of Liver Disease, approximately 80% individuals are chronically infected by the infection following exposure. Furthermore, chronic HCV can have serious consequences and might even prove to be fatal on being left untreated.
However, even if the company's HCV candidate manages to navigate through the clinical and regulatory hurdles, it will face tough competition in the hepatitis C market. This market has big players like Merck (MRK: 36.52 -0.08 -0.22%) and Roche (RHHBY: 0.00 N/A N/A). Moreover, companies like Valeant Pharmaceuticals (VRX: 25.87 +0.12 +0.47%), ZymoGenetics Inc. (ZGEN: 9.74 +0.01 +0.10%), which will be taken over by Bristol-Myers Squibb Co.
(BMY: 26.73 -0.55 -2.02%), are also developing treatments to combat HCV infection.
http://www.dailymarkets.com
Recently, Achillion Pharmaceuticals, Inc. (ACHN: 3.01 +0.05 +1.69%) announced that it has started dosing patients in a randomized, double-blind mid-stage study (n∼120) that will evaluate pipeline candidate ACH-1625. The candidate is being developed to treat patients infected with hepatitis C virus (HCV).
The placebo-controlled phase IIa study, to be conducted in the United States and Europe, will evaluate the safety, tolerability and antiviral activity of the HCV candidate as a combination therapy. Specifically, ACH-1625 (an oral candidate) will be evaluated in conjunction with pegylated interferon alfa-2a and ribavirin after 4 and 12 weeks of dosing in patients infected with chronic HCV genotype 1. While results from the 4 week study are expected in the first quarter of 2011, the 12 week study results are anticipated by the end of 2011.
ACH-1625, a HCV inhibitor molecule which has fared well in earlier studies, is an important candidate for Achillion. The candidate, on successful development and commercialization, will target the highly lucrative HCV market with a huge unmet need.
HCV infection is estimated to affect more than 170 million people across the globe. Moreover, according to estimates released by the American Association of Liver Disease, approximately 80% individuals are chronically infected by the infection following exposure. Furthermore, chronic HCV can have serious consequences and might even prove to be fatal on being left untreated.
However, even if the company's HCV candidate manages to navigate through the clinical and regulatory hurdles, it will face tough competition in the hepatitis C market. This market has big players like Merck (MRK: 36.52 -0.08 -0.22%) and Roche (RHHBY: 0.00 N/A N/A). Moreover, companies like Valeant Pharmaceuticals (VRX: 25.87 +0.12 +0.47%), ZymoGenetics Inc. (ZGEN: 9.74 +0.01 +0.10%), which will be taken over by Bristol-Myers Squibb Co.
(BMY: 26.73 -0.55 -2.02%), are also developing treatments to combat HCV infection.
Friday, October 1, 2010
Trial ACH-1625/ HCV protease inhibitor
Achillion Announces Dosing of First Patient in Phase II Trial of ACH-1625 for the Treatment of Hepatitis C
NEW HAVEN, Conn., Sep 30, 2010 (GlobeNewswire via COMTEX News Network) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.
The clinical trial is a Phase IIa, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin after 28 days of dosing and after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1. The trial will take place in the United States and Europe and is designed to enroll approximately 120 HCV-infected patients. The 28-day and 12-week trial data are anticipated to be announced in the first and fourth quarters of 2011, respectively.
"This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "The results will also provide important combination data for use of ACH-1625 with standard of care. We anticipate that the 28-day segment of the trial will provide us with rapid viral response (RVR) data early next year, and that the 12-week segment will provide extended viral response (cEVR) data by the end of next year."
"The initiation of Phase II dosing for ACH-1625 is a very important step in further solidifying this compound's profile as a potentially best-in-class protease inhibitor for HCV treatment," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "We believe ACH-1625 has the potential to provide an improved safety and tolerability profile, a more convenient dosing schedule and an extended period of viral suppression compared to currently available treatments for HCV-infected patients."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies completed to date, subjects receiving both single and multiple ascending doses ranging from 50 mg to 2000 mg for periods up to 5 days demonstrated that ACH-1625 was well tolerated at all doses and there were no serious adverse events, and no clinically significant changes in vital signs, electrocardiograms (ECGs) or laboratory evaluations. HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
About HCV
The hepatitis C virus (HCV) is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, injectable route of administration and high cost.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease --hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-1625, which may not be duplicated in future cohorts at different doses or in future clinical studies of longer duration; Achillion's expectations regarding timing and duration of other clinical trials, including additional dosing cohorts. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are uncertainties relating to results of clinical trials and unexpected regulatory actions or delays. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
ACHN-G
This news release was distributed by GlobeNewswire, http://www.globenewswire.com/
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Achillion Pharmaceuticals, Inc.
Mary Kay Fenton
(203) 624-7000
mfenton@achillion.com
Lippert/Heilshorn & Associates, Inc.
Anne Marie Fields
(212) 838-3777
afields@lhai.com
Bruce Voss
(310) 691-7100
bvoss@lhai.com
NEW HAVEN, Conn., Sep 30, 2010 (GlobeNewswire via COMTEX News Network) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has initiated patient dosing in a Phase II clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) infection. ACH-1625 is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication. The drug candidate was discovered and is being advanced by Achillion.
The clinical trial is a Phase IIa, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability and antiviral activity of oral ACH-1625 in combination with pegylated interferon alfa-2a and ribavirin after 28 days of dosing and after 12 weeks of dosing in subjects with chronic hepatitis C virus genotype 1. The trial will take place in the United States and Europe and is designed to enroll approximately 120 HCV-infected patients. The 28-day and 12-week trial data are anticipated to be announced in the first and fourth quarters of 2011, respectively.
"This Phase II clinical trial will allow us to establish the most appropriate once-daily dose to use in longer-term trials, and will augment our existing safety database for ACH-1625 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "The results will also provide important combination data for use of ACH-1625 with standard of care. We anticipate that the 28-day segment of the trial will provide us with rapid viral response (RVR) data early next year, and that the 12-week segment will provide extended viral response (cEVR) data by the end of next year."
"The initiation of Phase II dosing for ACH-1625 is a very important step in further solidifying this compound's profile as a potentially best-in-class protease inhibitor for HCV treatment," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "We believe ACH-1625 has the potential to provide an improved safety and tolerability profile, a more convenient dosing schedule and an extended period of viral suppression compared to currently available treatments for HCV-infected patients."
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In clinical studies completed to date, subjects receiving both single and multiple ascending doses ranging from 50 mg to 2000 mg for periods up to 5 days demonstrated that ACH-1625 was well tolerated at all doses and there were no serious adverse events, and no clinically significant changes in vital signs, electrocardiograms (ECGs) or laboratory evaluations. HCV-infected patients receiving doses ranging from 200 to 600 mg twice daily, and 400 to 600 mg once daily, showed mean maximal reductions in viral load ranging from of 3.07 log10 to 4.25 log10. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 1log10 from baseline through day 12, the last day of viral load measurement in the study.
About HCV
The hepatitis C virus (HCV) is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, injectable route of administration and high cost.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease --hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-1625, which may not be duplicated in future cohorts at different doses or in future clinical studies of longer duration; Achillion's expectations regarding timing and duration of other clinical trials, including additional dosing cohorts. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are uncertainties relating to results of clinical trials and unexpected regulatory actions or delays. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
ACHN-G
This news release was distributed by GlobeNewswire, http://www.globenewswire.com/
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Achillion Pharmaceuticals, Inc.
Mary Kay Fenton
(203) 624-7000
mfenton@achillion.com
Lippert/Heilshorn & Associates, Inc.
Anne Marie Fields
(212) 838-3777
afields@lhai.com
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Subscribe to:
Posts (Atom)