EASL: Idenix Reports Favorable Resistance Profile for IDX719

Idenix Reports Favorable Resistance Profile for IDX719, a Potent, Pan-Genotypic HCV NS5A Inhibitor, at EASL Meeting

CAMBRIDGE, Mass., April 24, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported detailed resistance data from in vitro studies and from a three-day monotherapy clinical trial of IDX719, the Company's once-daily, potent, pan-genotypic NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection. These data are being presented on Saturday, April 27, in a poster session at the 48^th Annual Meeting of the European Association for the Study of the Liver (EASL), which is being held April 24 - 28, 2013 in Amsterdam, The Netherlands.

Data from the three-day proof-of-concept study demonstrated that IDX719 was well-tolerated at daily doses up to 100 mg and showed potent antiviral activity across HCV genotypes 1-4, with mean maximal viral load reductions up to approximately 4.0 log₁₀ IU/mL. These data were supported by earlier in vitro findings. Clinical plasma samples at baseline, at end of treatment and at one week post-treatment were sequenced for mutations in NS5A at known IDX719 resistance-associated locations.

• The most common treatment-emergent resistant mutations were detected at NS5A positions 28, 31 and 93. The profile of these mutations varied among genotypes.
  
• The only resistance mutation present at baseline found to negatively affect IDX719 response was M31 in GT2-infected patients. In contrast, all GT4-infected patients had virus with M31 at baseline and responded favorably to IDX719 treatment.
  
• A GT1b-infected patient with a baseline Y93H mutation, which confers in vitro resistance to IDX719, achieved a 2.79 log₁₀ IU/mL viral load reduction after three days of once-daily 25 mg IDX719, indicating that IDX719 can retain activity against virus with known resistance mutations.

The poster presentation is titled, "Treatment-Emergent Variants Following 3 Days of Monotherapy with IDX719, a Potent, Pan-Genotypic NS5A Inhibitor, in Subjects Infected with HCV Genotypes 1-4" (Abstract No. 1209).

"These additional resistance data support the promising profile of IDX719 as a potent, pan-genotypic component of future HCV combination treatment regimens," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "We look forward to evaluating IDX719 as part of all-oral combination therapies through our collaboration with Janssen, beginning with the initiation of a phase II clinical trial of IDX719 and simeprevir in the first half of this year."

ABOUT IDX719

IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n=36; up to 7 days duration) and HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log₁₀ IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.

www.idenix.com.

EASL-Idenix will present data on IDX719

Idenix Announces Data Presentation at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL)

CAMBRIDGE, Mass., April 8, 2013 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it will present data on IDX719, the Company's pan-genotypic HCV NS5A inhibitor, at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) which is being held April 24 – 28, 2013 in Amsterdam, the Netherlands. Full abstracts can now be viewed at the EASL website at www.easl.eu.

McCarville, et al, "Treatment-Emergent Variants Following 3 Days of Monotherapy with IDX719, a Potent, Pan-Genotypic NS5A Inhibitor, in Subjects Infected with HCV Genotypes 1-4", will be presented in a poster session on Saturday, April 27.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix, please refer to www.idenix.com.

Forward-looking Statements

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are any expressed or implied statements with respect to: the Company's plans to continue to developing nucleotide polymerase inhibitors for HCV; its clinical development plans for its uridine nucleotide analog drug candidate and IDX719; its plans to advance other preclinical nucleotides; and statements regarding the efficacy and safety of its clinical compounds. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization due to numerous risks inherent in pharmaceutical research and development; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, preclinical and clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; competition; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.Idenix Pharmaceuticals Contacts: Kelly Barry (617) 995-9033 (media) Teri Dahlman (617) 995-9807 (investors)

Janssen and Idenix - The Newest Hep-C Partnership

Investment Commentary

Source - The Motley Fool

A collaboration between Janssen and Idenix is the highlight of this video. The collaboration will evaluate combinations using the following investigational HCV drugs; simeprevir formerly referred to as TMC435 a protease inhibitor developed by Janssen R&D Ireland and Medivir, TMC647055 a polymerase inhibitor by Janssen and Idenix's IDX719 a NS5A inhibitor. The clinical hold on IDX184 in relation to the outcome of Bristol-Myers tragic trial with drug BMS-986094 is also included in the video.




Related-

New Interferon-free Development Program
Alan Franciscus
Editor-in-Chief, HCV Advocate
January 28 2013 - Medivir announced a collaboration between Medivir/Janssen and Idenix for the clinical development of multiple HCV inhibitors with and without ribavirin—all the studies will be interferon-free.
Continue reading....

Press Release
Medivir: Phase II all-oral combination studies of Simeprevir, TMC647055 and IDX719 for the treatment of Hepatitis C to be initiated shortly

AASLD- Idenix Reports On IDX719 and IDX184

Idenix Pharmaceuticals Reports Clinical Data for HCV Drug Candidates - IDX719 and IDX184 - at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting

CAMBRIDGE, Mass., Nov. 10, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the presentation of safety and antiviral activity results for the Company's clinical-stage hepatitis C virus (HCV) drug candidates - IDX719, a next-generation pan-genotypic NS5A inhibitor, and IDX184, a nucleotide polymerase inhibitor.

Idenix presented updated clinical findings from a three-day proof-of-concept study, which demonstrated that IDX719 was well-tolerated at daily doses up to 100 mg and showed potent antiviral activity across HCV genotypes 1-4, with mean maximal viral load reductions up to approximately 4.0 log10 IU/mL. The Company also presented updated cardiovascular safety and antiviral activity data from the phase IIb study of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV). The IDX719 and IDX184 clinical data are being reported in poster presentations during the 63rd Annual Meeting for the American Association for the Study of Liver Diseases (AASLD) in Boston.

IDX719 three-day proof-of-concept study

Study design

The three-day proof-of-concept study evaluated IDX719 in 64 treatment-naïve, genotype 1, 2, 3 or 4 HCV-infected patients. Genotype 1 patients were randomized to receive placebo, 25 mg QD (once-daily), 50 mg QD, 50 mg BID (twice-daily) or 100 mg QD for three days. Genotype 2, 3 or 4 patients were randomized to receive placebo, 50 mg BID or 100 mg QD for three days.

Study results

• In genotype 1a patients (n=29), mean maximal viral load reductions ranged from 3.2 log10 IU/mL to 3.6 log10 IU/mL across treatment groups.
• In genotype 1b patients (n=5), mean maximal viral load reductions were 3.0 log10 IU/mL in the 25 mg QD arm, and 4.3 log10 IU/mL in the 50 mg QD arm.
• In genotype 2 patients (n=10), the mean maximal viral load reduction was 2.0 log10 IU/mL in both the 50 mg BID and 100 mg QD dose arms with a greater variability in responses among these patients (range: 0.3- 4.1 log10 IU/mL). Four of the genotype 2 patients responded well to IDX719 treatment, and four patients had maximal reductions that were less than 1.0 log10 IU/mL. The decrease in viral load response in genotype 2 patients was associated with the pre-existence or emergence of the M31 polymorphism in the HCV NS5A gene.
• In genotype 3 patients (n=10), mean maximal viral load reductions were 3.3 log10 IU/mL in the 50 mg BID arm and 3.4 log10 IU/mL in the 100 mg QD arm.
• In genotype 4 patients (n=10), mean maximal viral load reductions were 3.9 log10 IU/mL in the 50 mg BID dose arm and 3.6 log10 IU/mL in the 100 mg QD dose arm.

No patients experienced a rebound (> 1.0 log10 IU/mL increase over the lowest viral load) during the treatment period and maximum viral load reductions were typically achieved within 24-72 hours post dose. There were no safety-related discontinuations or serious adverse events. IDX719 was safe and well tolerated at daily doses up to 100 mg for three days. Idenix intends to initiate a phase II clinical trial evaluating IDX719 in combination therapy in 2013.

"To our knowledge, these are the most advanced clinical results validating the robust, pan-genotypic activity of an NS5A inhibitor in HCV," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "We look forward to advancing this promising drug candidate into the next phase of clinical testing."

IDX184 phase IIb combination study

Study design

A randomized, double-blind phase IIb clinical trial is evaluating IDX184 in 67 treatment-naive genotype 1 HCV-infected patients. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Response-guided therapy is used to complete an additional 12 or 36 weeks of PegIFN/RBV treatment.

Study results

All patients had completed treatment with IDX184 when in August 2012, the U.S. Food and Drug Administration (FDA) placed IDX184 on partial clinical hold due to cardiac adverse events seen in a competitor's phase II clinical trial evaluating BMS-986094. The overall safety profile of IDX184 in combination with PegIFN/RBV remains consistent with the known safety profile of PegIFN/RBV alone. In light of the clinical hold, Idenix has evaluated multiple cardiac safety measurements, including electrocardiograms, echocardiograms and two cardiac biomarkers, ultrasensitive troponins and NT-proBNPs, from the ongoing IDX184 phase IIb study and has found no evidence of severe cardiac findings to date.

Similar numbers of patients achieved a complete early virologic response (cEVR; virus levels < 25 IU/mL at 12 weeks) in the 50 mg (26/34; 76%) and in the 100 mg (27/33; 82%) groups. Rates of rapid virologic response (RVR; virus levels < 25 IU/mL at 4 weeks) were also comparable between the 50 mg (18/34; 53%) and the 100 mg (18/33; 55%) groups. The difference in response rates from data previously reported is primarily due to an increased number of genotype 1b patients as well as IL28B CT/TT patients who were enrolled in the second patient cohort. No patient experienced virologic breakthrough during the 12-week IDX184/Peg-IFN/RBV treatment period. The majority of patients are in the ongoing PegIFN/RBV extension treatment phase, and complete sustained virologic response (SVR) results will be available in 2013.

"The IDX184 presentation at AASLD details much of the key clinical data we intend to submit to the FDA in our response package by the end of the year," said Ron Renaud, Idenix's President and Chief Executive Officer. "As always, patient safety is our top priority, and I am pleased with the thoroughness with which our R&D team and the trial investigators have gathered this information and that there have been no treatment-emergent cardiac or renal serious adverse events (SAEs) to date in the ongoing IDX184 study."

ABOUT HEPATITIS C

Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 170 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 and IDX719; and the likelihood and success of any future clinical trials involving IDX184 or IDX719. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2011 and the quarterly report on Form 10-Q for the quarter ended September 30, 2012, each as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

CONTACT: Idenix Pharmaceuticals Contacts:
         Kelly Barry (617) 995-9033 (media)
         Teri Dahlman (617) 995-9807 (investors)

Idenix Reports Financial Results and HCV Program Update

Idenix Pharmaceuticals Reports Third Quarter and Nine Month 2012 Financial Results and HCV Program Update

CAMBRIDGE, Mass., Nov. 1, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the third quarter and nine months ended September 30, 2012 and provided an update of its hepatitis C virus (HCV) development programs.

 

HCV Pipeline and Third Quarter Business Review
IDX719, an NS5A inhibitor

• The Company previously reported early clinical results demonstrating a favorable safety profile and potent pan-genotypic activity for IDX719. Idenix anticipates that a phase II clinical trial evaluating IDX719 in combination therapy will begin in the first half of 2013.

Nucleotide polymerase inhibitor program

• In August 2012, the U.S. Food and Drug Administration (FDA) placed IDX184 on partial clinical hold due to serious cardiac--related adverse events seen with a competitor's nucleotide polymerase inhibitor, BMS-986094 (formerly INX-189). Idenix has obtained cardiac safety measurements from the ongoing phase IIb study of IDX184 in combination with pegylated interferon and ribavirin and has found no evidence of severe cardiac findings to date. Idenix is reviewing additional preclinical and clinical data and conducting further testing . The Company anticipates submitting the complete response package to the FDA by year-end.
• In July 2012, Idenix submitted an investigational new drug (IND) application for IDX19368, a 2'methyl guanosine nucleotide inhibitor. In August 2012, FDA placed IDX19368 on clinical hold due to serious cardiac-related adverse events seen with BMS-986094 and has requested additional toxicology and metabolic preclinical studies for IDX19368 prior to permitting the initiation of clinical studies.
• As part of the ongoing extensive nucleotide discovery effort, the Company is exploring a diverse spectrum of nucleotides with novel bases, prodrugs and sugar moieties. IND-enabling studies have begun for a new nucleotide prodrug and an IND is expected to be filed in 2013.

"We are working diligently to assemble all of the data requested by the FDA regarding IDX184, and we expect to receive a response from the FDA in early 2013," said Ron Renaud, Idenix's President and Chief Executive Officer. "We also are excited about IDX719, a potentially best-in-class pan-genotypic NS5A inhibitor, and look forward to moving it into phase II clinical development in the near term. Additionally, in 2013 we expect to see the results of our robust discovery efforts focused on next-generation nucleotide inhibitors, with the objective of filing at least one IND next year."
Renaud continued, "Our goal remains to develop an all-oral pan-genotypic regimen that will play a significant role in future HCV treatments. With a strong cash position and the restructured Novartis collaboration, we are able to maximize opportunities for advancing our programs in order to achieve that goal."

Upcoming Meeting
The 63^rd Annual Meeting for the American Association for the Study of Liver Diseases (AASLD) will take place in Boston from November 9 -- November 13, 2012.

• A poster titled "IDX719, HCV NS5A Inhibitor, Demonstrates Pan-Genotypic Activity after Three Days of Monotherapy in Genotype 1, 2, 3 or 4 HCV-Infected Subjects," by D. Mayers, et al, will be presented on November 13 at 8:00 am ET.
• A poster titled "High Rates of Rapid Virologic Response (RVR) and Complete Early Virologic Response (cEVR) with IDX184, Pegylated Interferon and Ribavirin in Genotype 1 HCV-Infected Subjects: Interim Results," by E. Lawitz, et al, will be presented on November 13, 2012 at 8:00 am ET.

Continue Reading...

IDX719-Idenix hepatitis C drug Receives Fast Track Designation

July 25, 2012

 

IDX719 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C Infection

CAMBRIDGE, Mass., July 25, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IDX719 for the treatment of chronic hepatitis C infection (HCV). IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.

"We are pleased and encouraged by the receipt of Fast Track designation from the FDA for IDX719 as we believe this reflects the critical need for new treatment regimens to address HCV infection," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We remain focused on executing our goal of creating an interferon-free direct acting antiviral combination to cure HCV for a patient population that currently has limited treatment options. As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year."

Under the FDA Modernization Act of 1997, Fast Track designation may potentially expedite the review of a drug that is intended for the treatment of a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need for such a condition. The Fast Track program enables a company to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, rather than waiting for the entire submission 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 would reduce the length of the standard FDA review period.

ABOUT IDX719
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, IDX719 has been safe and well tolerated after single and multiple doses of up to 100 mg in healthy volunteers (n=36; up to 7 days duration) and HCV-infected patients (n=69; up to 3 days duration). There have been no treatment-emergent serious adverse events reported in the program. IDX719 has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients. Maximal viral load reductions were > 3 log10 after a single 100 mg dose in an exploratory cohort of genotype 1, 2 and 3 HCV-infected patients. These results have been confirmed in a subsequent proof-of-concept, three-day monotherapy study. After administration of 100 mg IDX719 once daily for 3 days, mean maximal viral load reductions were > 3.4 log10 in genotype 1, 3 and 4 HCV-infected patients. There was greater variability in responses among genotype 2 HCV-infected patients, who had mean maximal viral load reductions of 2.0 log10. The Company is currently conducting pharmacokinetic and sequencing analyses to further characterize these results.

ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates; and the successful development of novel combinations of direct-acting antivirals for the treatment of HCV. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2012, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

CONTACT: Idenix Pharmaceuticals Contacts:

         Kelly Barry (617) 995-9033 (media)

         Daniella Beckman (617) 224-4471 (investors)

Source: Idenix Pharmaceuticals


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Idenix: New HCV Drug Could Be A Blockbuster

Idenix: New HCV Drug Could Be A Blockbuster

Cris Frangold

Seeking Alpha

Idenix Pharmaceuticals, Inc. (IDIX) recently announced encouraging initial results from Phase IIb results for the treatment - namely, IDX184 and IDX719 - of the hepatitis C virus (HCV). Some reports about HCV say that it affects more than 170 million people globally, including over 4 million Americans. The global market for an effective treatment could reach as high as $100 billion by the year 2020.

HCV infects people who come in contact with contaminated blood that carries the virus, and is one of the main causes of chronic liver disease, which may end up as liver cancer. The result is also an increase in the number of liver transplants for people who contract the disease. The present treatment, which includes injections of the drug interferon alpha, cannot be tolerated by some patients, and can result in side-effects such as fever and depression.

Experts in the field say that this is a landmark moment in the treatment of HCV, because these results show that it is possible to treat the disease without using interferon. There is potential that these two drugs, with complementary profiles, can be given orally and eradicate the virus. The stage has been set for devising a treatment for effecting a complete cure among a large number of people. Experts also feel that the IDX 184 drug from Idenix can be used as a patch, and may overcome its deficiencies if it is combined with another potent drug such as Merck's (MRK) MK-5172/Victrelis (boceprevir), which has already been approved by the FDA.

With so many companies developing and testing treatments for HCV, it is worth our time to briefly survey the current developments. Idenix itself has produced some encouraging news about clinical trials for one of its new hepatitis C drug treatments, IDX719. The study measured a number of things, including the interaction between patient safety and food, and the effectiveness of the drug treatment.

In all, 40 volunteer patients took part in the trial, of which eight were given IDX 719. The volunteers reacted well to the drug, and have provided the company with positive feedback so that the trials can be continued. The company has also planned to begin trials with a combination of IDX 719 and IDX 184 towards the end of this year. Meanwhile, clinical trials on both drugs will continue to enable the company to gather as much data as possible before applying for FDA approval.

So many big companies are now involved in developing and testing drugs for HCV, that investors are asking whether they should invest in smaller companies, like Idenix, or look to larger pharmaceutical companies. Obviously, with the successful clinical trials to date, Idenix has to be taken seriously, but it may be appropriate to examine what the competition is doing. HCV drugs have recently become popular with investors because of the size of the potential market and the problems with the existing treatments for the disease. A successful treatment that would kill the virus, or at least keep it dormant, will help millions of people, and be extremely profitable for the company concerned.

Abbott Laboratories (ABT) has recently provided information on its pipeline drugs. Two short studies have shown recovery rates that are significant among the participants. The studies showed cure rates of 95% and 93%, respectively, for patients taking other HCV treatments, and 47% of patients not taking any other treatments. A cure rate refers to stopping or slowing down the spread of the virus, though the damage the virus has already caused cannot be reversed with these drugs. The company has started Phase II clinical trials, and will proceed to Phase III clinical trials before applying for FDA approval to manufacture and sell the drug treatment.

Gilead Sciences (GILD) also has a drug called GS-7977, which it took over when it acquired Pharmasset in late 2011. Gilead, is best known for its HIV drug treatments, Truvada and Viread. This HCV drug could become formidable competition for Index and other companies if it performs well in upcoming clinical trials. Gilead is under pressure, however, as its HIV drug treatments will lose patent protection by the end of the decade, and become vulnerable to low-cost generic producers.

Vertex Pharmaceuticals (VRTX) and Merck, two other companies developing new drug treatments for Hepatitis C, are also powerful competitors, and the recent problems that Vertex has had in respect of its data on Incivek do not take away from the effectiveness of the treatment. Finally, Medivir (MVIRB), working with Johnson & Johnson (JNJ), has reported good results with its drug TMC435. The company conducted a trial that resulted in an 80% 'cure' rate for volunteers who took the drug for 48 weeks and, within 24-weeks post-treatment, the virus disappeared.

Idenix has a robust drug pipeline centered on treatments for HCV. The company is investigating three separate classes of drugs. It has already been successful in developing and launching the licensed hepatitis B drug candidate, Telbivudine. The company has collaborations with other well-known companies, such as Novartis (NVS) and GlaxoSmithKline (GSK). These collaborations have produced several drugs such as IDX375 and IDX136. The company's best chance for a blockbuster is IDX184.

I have never believed that promising biotech investments can be identified with the use of conventional techniques and ratios involving past financial performance. A new blockbuster drug can be a complete game changer for a company. The kind of returns that are possible can easily outweigh the high risk and the process of waiting on FDA approvals. Idenix has a good track record, as well as a stellar product that could be a breakthrough in the potentially enormous HCV treatment market. If you can tolerate the risk of biotech investments, I would strongly recommend buying Idenix now.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Source

HCV Drug Candidates IDX184 and IDX719-Idenix Announces Positive Clinical Data

Idenix hep C drug shows promise in mid-stage study (Reuters)

Idenix Pharmaceuticals Inc said interim data from a mid-stage trial on its experimental hepatitis C drug showed promise, sending its shares up 12 percent.

The drug, IDX184, was given to 31 patients in combination with the standard hep C treatments pegylated interferon and ribavirin.

Nine patients received the combination therapy for 12 extended weeks and were checked four weeks later for signs of the virus in the blood to determine if there was a sustained virologic response, or SVR.

All four patients in the 100 mg arm and four out of five patients in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment.

Patients who did not have undetectable levels of virus at 4 weeks and 12 weeks automatically entered the 36-week combination therapy extended treatment phase which is ongoing, the company said.
Idenix shares rose 12 percent to $10.45 in extended trade, after closing at $9.37 on Tuesday on the Nasdaq.

(Reporting by Shailesh Kuber in Bangalore; Editing by Saumyadeb Chakrabarty)
http://www.reuters.com/article/2012/06/19/us-idenixpharmaceuticals-brief-idUSBRE85I1N220120619
Source: Idenix Pharmaceuticals
Date: June 19, 2012 16:06 ET

Idenix Announces Positive Clinical Data for HCV Drug Candidates IDX184 and IDX719

In an Interim Analysis From an Ongoing Phase IIb Clinical Trial of IDX184, an HCV Nucleotide Inhibitor, 89% of Patients Who Completed an Additional 12 Weeks of Pegylated Interferon Plus Ribavirin Treatment Achieved SVR4; 100% (4/4) in 100 mg Arm and 80% (4/5) in 50 mg Arm

IDX719, an HCV NS5A Inhibitor, Achieves Potent Pan-Genotypic Activity in Three-Day Proof-of-Concept Clinical Trial

CAMBRIDGE, Mass., June 19, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced results from an ongoing phase IIb study of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV). Of the first cohort of 31 patients enrolled in the study, those who achieved an eRVR (n=18), defined as having undetectable levels of virus at 4 weeks and 12 weeks, were randomized to stop treatment after either an additional 12 weeks (n=9) or 36 weeks (n=9) of PegIFN/RBV. Of the nine patients who completed their 12-week PegIFN/RBV extended treatment phase, 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4). Patients who did not achieve an eRVR automatically entered the 36-week PegIFN/RBV extended treatment phase which is ongoing. To date, the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.

"We are encouraged by the initial SVR results from the phase IIb program, which have confirmed previous data showing that IDX184 is a potent nucleotide inhibitor with a profile supporting its potential role as a key component of all-oral direct-acting antiviral (DAA) combination regimens for HCV," stated Ron Renaud, President and Chief Executive Officer of Idenix. "We look forward to initiating interferon-free DAA combination studies in the near term."

IDX184 Phase IIb Study Design

In July 2011, the company initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Response-guided therapy was used to complete an additional 12 or 36 weeks of PegIFN/RBV treatment. Study objectives include safety and tolerability, and antiviral activity endpoints.

IDX719 Proof-of-Concept Clinical Trial Data and Study Design

Idenix also announced today positive data from a three-day proof-of-concept study evaluating IDX719, an NS5A inhibitor, in 64 treatment-naïve, genotype 1, 2, 3 or 4 HCV-infected patients. Genotype 1 patients were randomized to receive placebo, 25 mg QD (once-daily), 50 mg QD, 50 mg BID (twice-daily) or 100 mg QD for three days. Genotype 2, 3 or 4 patients were randomized to receive placebo, 50 mg BID or 100 mg QD for three days.

IDX719 was well tolerated with no serious adverse events reported. Treatment with IDX719 exhibited potent pan-genotypic activity across genotypes:

In genotype 1 patients (n=28), mean maximal viral load reductions were 3.2 log10 IU/mL in the 25 mg QD arm, 3.7 log10 IU/mL in the 50 mg QD arm, 3.2 log10 IU/mL in the 50 mg BID arm and 3.5 log10 IU/mL in the 100 mg QD arm.
In genotype 2 patients (n=8), the mean maximal viral load reduction was 2.0 log10 IU/mL in both the 50 mg BID and 100 mg QD dose arms with a greater variability in responses among these patients (range: 0.3 – 4.1 log10 IU/mL). The company is currently conducting pharmacokinetic and sequencing analyses to further characterize these results.
In genotype 3 patients (n=8), mean maximal viral load reductions were 3.3 log10 IU/mL in the 50 mg BID arm and 3.4 log10 IU/mL in the 100 mg QD arm.
In genotype 4 patients (n=7), mean maximal viral load reductions were 3.9 log10 IU/mL in the 50 mg BID dose arm and 3.4 log10 IU/mL in the 100 mg QD dose arm.
More detailed findings are expected to be presented at a scientific meeting in the second half of 2012.

"We are pleased to demonstrate the first clinical validation of IDX719 in patients in a multiple-dose study with robust activity across multiple HCV genotypes," commented Douglas Mayers, M.D., Chief Medical Officer of Idenix. "Given these promising findings, we look forward to initiating a phase II combination study of IDX719 with IDX184 by the end of this year."

ABOUT IDX184

IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. In the ongoing phase IIb clinical trial, IDX184 has been well tolerated with a side effect profile similar to that of PegIFN/RBV. In the first cohort of 31 patients, at 12 weeks in an intent-to-treat analysis, the complete early virologic response (< 25 IU/mL at 12 weeks) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study. The company completed enrollment of a second cohort of 36 additional patients in May 2012.

ABOUT IDX719

IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. In 36 healthy volunteers, IDX719 was safe and well tolerated at single doses of 5-100 mg as well as multiple doses of 100 mg for 7 days. Single doses of IDX719 demonstrated potent pan-genotypic antiviral activity in 18 genotype 1, 2 or 3 HCV-infected patients, with greater than 3 log10 viral load reductions achieved in the 100 mg dose arm.

ABOUT HEPATITIS C

Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 170 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 or IDX719 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; the likelihood and success of any future clinical trials involving our drug candidates; and expectations with respect to future milestone or royalty payments, funding of operations and future cash balances. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the Company's dependence on its collaboration with Novartis; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2011 and quarterly report on Form 10-Q for the quarter ended March 31, 2012, each as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors)

http://www.globenewswire.com/newsroom/news.html?d=259734

Idenix Pharmaceuticals Provides Update on Hepatitis C Clinical Development Programs

April 19, 2012

Idenix Pharmaceuticals Provides Update on Hepatitis C Clinical Development Programs

IDX719 Demonstrates Pan-Genotypic Activity at Single Doses in HCV-Infected Patients Achieving Greater Than 3 log10 Viral Load Reductions in the 100 mg Dose Group Across Genotypes 1, 2 and 3; Three-Day Proof-of-Concept Study Underway

IDX184/PegIFN/RBV Phase IIb Study Fully Enrolled

CAMBRIDGE, Mass., April 19, 2012 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced data from a phase I clinical trial of IDX719, an NS5A inhibitor for the treatment of hepatitis C virus (HCV) infection, demonstrating potent pan-genotypic antiviral activity with single doses.

In January 2012, Idenix initiated a phase I clinical study of IDX719. The first part of the study evaluated the safety, pharmacokinetics and food effect of IDX719 in 40 healthy volunteers at single doses ranging from 5 to 100 mg. Eight healthy volunteers received 100 mg of IDX719 daily for seven days. All doses were well tolerated and pharmacokinetic data supports once-daily dosing in future studies. In the second part of the phase I study, single-ascending doses of IDX719 achieved substantial viral load reductions in the following cohorts of HCV-infected patients:

• A cohort of 12 HCV genotype 1-infected patients received single IDX719 doses of 1, 5, 10, 25, 50 or 100 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log10, 2.6 log10, 3.3 log10, 3.7 log10, 2.8 log10 and 3.5 log10, respectively;

• A cohort of three HCV genotype 2-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 0.4 log10, 3.2 log10 and 3.5 log10, respectively; and

• A cohort of three HCV genotype 3-infected patients received single IDX719 doses of 25, 50 or 100 mg (1 patient per dose). Maximal viral load reductions were 2.2 log10, 3.7 log10 and 3.3 log10, respectively.

The single-dose data were presented at the Cambridge Healthtech Institute's 5th Annual HCV Drug Discovery meeting this week in San Diego, California. A three-day proof-of-concept study has initiated dosing and is designed to evaluate 64 treatment-naïve genotype 1, 2, 3 or 4 HCV-infected patients.

"These single-dose IDX719 data show potent viral load reductions, with some patients maintaining viral suppression out to three days," said Douglas Mayers, Chief Medical Officer of Idenix Pharmaceuticals. "We are pleased with the promising antiviral activity in genotypes 1, 2 and 3, and we look forward to seeing multiple-dose data in a larger number of patients from the ongoing three-day proof-of-concept study."

Additionally, Idenix has completed enrollment of the second cohort of 30 patients in the ongoing 12-week phase IIb study of IDX184, an HCV nucleotide inhibitor, in combination with pegylated interferon and ribavirin (PegIFN/RBV). IDX184 continues to be safe and well tolerated with no treatment-emergent serious adverse events reported and a side effect profile similar to that of PegIFN/RBV. As the study currently remains blinded, further data from the ongoing clinical trial will be available in the second half of 2012.

"Idenix's clinical programs have made significant progress in the past few months. For IDX184, we are looking forward to initiating a combination study with a protease inhibitor and ribavirin in the near-term to establish the safety and potency of an all-oral IDX184-containing regimen, and, if successful, potentially support a phase III clinical program," said Ron Renaud, Idenix's President and Chief Executive Officer. "We are also very pleased with the early viral load reduction data for IDX719. Our ultimate goal is to advance a proprietary, pan-genotypic HCV treatment regimen. We intend to evaluate the combination of IDX184 and IDX719 in a clinical trial that is planned to begin by the end of this year."

ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com .

FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 or IDX719 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; the likelihood and success of any future clinical trials involving our drug candidates; and expectations with respect to future milestone or royalty payments, funding of operations and future cash balances. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the Company's dependence on its collaboration with Novartis; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors) Source: Idenix Pharmaceuticals

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