Medivir: Interim results (SVR4) from a phase II all-oral combination study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C
STOCKHOLM, Sweden--(BUSINESS WIRE)--January 13, 2014--
Regulatory News:
Sweden--Medivir AB (STO:MVIR-B), announces that Idenix Pharmaceuticals, Inc. today released interim data from the ongoing phase II HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (IDX719), Idenix's once-daily pan-genotypic NS5A inhibitor, and simeprevir , a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and ribavirin.
The combination regimen of the study was well-tolerated. In the treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients receiving 50 mg of samatasvir and 150 mg of simeprevir plus ribavirin for 12 weeks, 85 percent (n=17/20) of the patients achieved SVR4 (undetectable HCV RNA four weeks after end of treatment). The 50 mg dose of samatasvir is the selected dose in the ongoing 3-DAA HELIX-2 clinical trial. The HELIX-1 study results are expected to be presented at a scientific meeting in 2014.
HELIX-1 study design The HELIX-1 trial is the first study in HCV-infected patients to commence under a non-exclusive collaboration agreement between Idenix and Janssen which was established in January 2013. The HELIX-1 trial is a phase II 12-week, randomized, parallel group study evaluating the antiviral activity, safety and tolerability of samatasvir and simeprevir in treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients.
Patients in part A of the study (n=63) were enrolled in one of three treatment groups receiving 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with 150 mg of simeprevir plus a weight-based dose of ribavirin. In part B of the ongoing HELIX-1 study, exploratory cohorts of patients have been added to evaluate the safety and antiviral activity of a 25 mg dose of samatasvir in genotype 1b-infected patients and of a 100 mg dose of samatasvir in genotype 6-infected patients.
A second phase II trial (HELIX-2) was initiated in December 2013 evaluating samatasvir, simeprevir and TMC647055, a once-daily non-nucleoside polymerase inhibitor plus a low-dose ritonavir being developed by Janssen, with and without ribarivin in genotype 1-infected patients who are either treatment-naïve or have previously relapsed after treatment with pegylated interferon and ribavirin.
For additional information about the HELIX-1 study, please visit www.clinicaltrials.gov
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 13.15 p.m. CET on 13 January 2014.
About Simeprevir Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 and 4 infected subjects with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan (trade name Sovriad(TM)) and in the USA (trade name Olysio(TM)) and Canada (trade name Galexos(TM)) in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 and genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About Samatasvir (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers up to 14 days duration, and in HCV-infected patients up to 12 weeks duration. There have been no treatment-emergent serious adverse events reported in the program. Samatasvir 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.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company's website: www.medivir.com
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Showing posts with label Simeprevir/Samatasvir (IDX719). Show all posts
Showing posts with label Simeprevir/Samatasvir (IDX719). Show all posts
Monday, January 13, 2014
Thursday, December 12, 2013
All-oral study with Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated
Idenix, Janssen begin phase 2 study of all-oral DAA therapy for HCV
Idenix Pharmaceuticals and Janssen Pharmaceuticals have begun enrollment in a phase 2 clinical trial to evaluate an all-oral, direct-acting antiviral combination for treatment of hepatitis C, according to an Idenix news release.
The 12-week HELIX-2 trial will analyze response to a combined treatment of samatasvir, a pan-genotypic NS5A inhibitor from Idenix; simeprevir, an NS3/4A protease inhibitor from Janssen R&D Ireland and Medivir AB; and TMC647055, an NS5B non-nucleoside polymerase inhibitor from Janssen, the release said.
The randomized, open-label trial will study treatment-naive HCV patients, as well as those who have relapsed after treatment with ribavirin and interferon. Patients will receive 50 mg samatasvir, 75 mg simeprevir and 450 mg TMC647055 boosted by 30 mg ritonavir once daily for 12 weeks, with or without ribavirin.
The trial is the second as part of a collaboration agreement between Idenix and Janssen. The HELIX-1 trial studying samatasvir and simeprevir is ongoing, the release said.
“We are pleased with the continuing progress of our clinical program for samatasvir, which will provide additional important information on the use of this promising compound as part of all-oral HCV combination regimens,” Doug Mayers, MD, Idenix’s chief medical officer, said in the release. “With the advancement of the samatasvir program, as well as that of our novel nucleotide prodrug inhibitor, IDX21437, we anticipate initiating the evaluation of our own HCV combination regimen in 2014.”
http://www.healio.com/infectious-disease/hepatitis-resource-center-2013/idenix-janssen-begin-phase-2-study-of-all-oral-daa-therapy-for-hcv
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated
Stockholm, Sweden—Medivir AB (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.
Study design
Approximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the co-administration of simeprevir, TMC647055 and two different doses of JNJ56914845 without ribavirin. The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 30 or 60 mg of JNJ56914845 and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks.
For additional information about this study, please visit www.clinicaltrials.gov
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 a.m. CET on 12 December 2013.
About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected patients with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in phase II clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
About JNJ56914845
JNJ56914845, is a potent NS5A replication complex inhibitor. To date phase I and phase II clinical studies conducted demonstrated that JNJ56914845 60 mg once daily is well tolerated and produces rapid, substantial decreases in HCV RNA in treatment-naïve CHC subjects when given alone as a single dose and for 4 weeks in combination with pegIFN and RBV.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
Idenix Pharmaceuticals and Janssen Pharmaceuticals have begun enrollment in a phase 2 clinical trial to evaluate an all-oral, direct-acting antiviral combination for treatment of hepatitis C, according to an Idenix news release.
The 12-week HELIX-2 trial will analyze response to a combined treatment of samatasvir, a pan-genotypic NS5A inhibitor from Idenix; simeprevir, an NS3/4A protease inhibitor from Janssen R&D Ireland and Medivir AB; and TMC647055, an NS5B non-nucleoside polymerase inhibitor from Janssen, the release said.
The randomized, open-label trial will study treatment-naive HCV patients, as well as those who have relapsed after treatment with ribavirin and interferon. Patients will receive 50 mg samatasvir, 75 mg simeprevir and 450 mg TMC647055 boosted by 30 mg ritonavir once daily for 12 weeks, with or without ribavirin.
The trial is the second as part of a collaboration agreement between Idenix and Janssen. The HELIX-1 trial studying samatasvir and simeprevir is ongoing, the release said.
“We are pleased with the continuing progress of our clinical program for samatasvir, which will provide additional important information on the use of this promising compound as part of all-oral HCV combination regimens,” Doug Mayers, MD, Idenix’s chief medical officer, said in the release. “With the advancement of the samatasvir program, as well as that of our novel nucleotide prodrug inhibitor, IDX21437, we anticipate initiating the evaluation of our own HCV combination regimen in 2014.”
http://www.healio.com/infectious-disease/hepatitis-resource-center-2013/idenix-janssen-begin-phase-2-study-of-all-oral-daa-therapy-for-hcv
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated
Stockholm, Sweden—Medivir AB (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor.
Study design
Approximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the co-administration of simeprevir, TMC647055 and two different doses of JNJ56914845 without ribavirin. The trial will evaluate genotype 1a and 1b HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 30 or 60 mg of JNJ56914845 and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks.
For additional information about this study, please visit www.clinicaltrials.gov
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 a.m. CET on 12 December 2013.
About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected patients with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in phase II clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
About JNJ56914845
JNJ56914845, is a potent NS5A replication complex inhibitor. To date phase I and phase II clinical studies conducted demonstrated that JNJ56914845 60 mg once daily is well tolerated and produces rapid, substantial decreases in HCV RNA in treatment-naïve CHC subjects when given alone as a single dose and for 4 weeks in combination with pegIFN and RBV.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
Monday, December 2, 2013
Medivir: HELIX-2, phase II all-oral study of Simeprevir, TMC647055 and Samatasvir (IDX719) for hepatitis C has been initiated
Press releases - Published Monday, 02 December 2013 14:11
Medivir: HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated
Press release published at The Swedish Wire
Stockholm, Sweden-Medivir AB (OMX: MVIR), announces that IDENIX has initiated a phase II clinical trial (HELIX-2) evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, samatasvir and TMC647055 with a pharmacokinetic enhancer.
The HELIX-2 trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of simeprevir, TMC647055 and samatasvir. The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 50 mg samatasvir and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks, with or without the addition of ribavirin.
The HELIX-2 trial is the second study in HCV-infected patients to commence under a non-exclusive collaboration agreement between Idenix and Janssen established in January 2013. The HELIX-1 trial of samatasvir in combination with simeprevir was initiated in May 2013 and is ongoing.
For additional information about this study, please visit www.clinicaltrials.gov
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected subjects with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in phase II clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
About Samatasvir (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers up to 14 days duration, and in HCV-infected patients up to 12 weeks duration. There have been no treatment-emergent serious adverse events reported in the program. Samatasvir 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.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company's website: www.medivir.com
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people's health and quality of life.
This information was distributed by Cision
Medivir: HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated
Press release published at The Swedish Wire
Stockholm, Sweden-Medivir AB (OMX: MVIR), announces that IDENIX has initiated a phase II clinical trial (HELIX-2) evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, samatasvir and TMC647055 with a pharmacokinetic enhancer.
The HELIX-2 trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of simeprevir, TMC647055 and samatasvir. The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will receive 75 mg of simeprevir, 50 mg samatasvir and 450 mg of TMC647055 plus a low dose of ritonavir as a pharmacokinetic enhancer, each once daily for 12 weeks, with or without the addition of ribavirin.
The HELIX-2 trial is the second study in HCV-infected patients to commence under a non-exclusive collaboration agreement between Idenix and Janssen established in January 2013. The HELIX-1 trial of samatasvir in combination with simeprevir was initiated in May 2013 and is ongoing.
For additional information about this study, please visit www.clinicaltrials.gov
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and Janssen R&D Ireland for the treatment of chronic hepatitis C infection in combination with other antivirals in HCV genotype 1 & 4 infected subjects with compensated liver disease, including cirrhosis.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in the USA and Canada in November. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
About TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase inhibitor with broad genotypic coverage. TMC647055 is in phase II clinical development and is developed by Janssen R&D Ireland to treat chronic hepatitis C virus infections. TMC647055 is being investigated in combination with other DAA agents in all oral interferon-free regimens. There have been no treatment-emergent serious adverse events reported in the program.
About Samatasvir (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers up to 14 days duration, and in HCV-infected patients up to 12 weeks duration. There have been no treatment-emergent serious adverse events reported in the program. Samatasvir 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.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company's key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company's website: www.medivir.com
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people's health and quality of life.
This information was distributed by Cision
Thursday, May 30, 2013
Janssen/Idenix Collaborate: Simeprevir and Samatasvir (IDX719) All-oral combination phase II trial for the treatment of hepatitis C
An all-oral combination phase II study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C virus infection initiated
· Phase II HELIX-1 trial is first hepatitis C clinical study to commence through collaboration agreement between Janssen Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc.
30-May-13
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that Idenix Pharmaceuticals Inc. has initiated a phase II clinical trial, called HELIX-1, evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, a once-daily protease inhibitor jointly developed by Medivir and Janssen R&D Ireland and samatasvir (IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor.
“Hepatitis C is a complex disease and there is a need for multiple treatment options. Future hepatitis C treatment will be interferon free and will consist of two to three direct acting antivirals (DAAs). We are pleased and looking forward to having simeprevir evaluated in this two-direct-acting antiviral phase II study”, said Charlotte Edenius, EVP Development, Medivir AB.
About the HELIX trial
The HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of simeprevir and samatasvir in addition to antiviral activity endpoints, with a target enrollment of 90 treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients.
Patients will be randomized equally across three treatment arms, receiving 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with 150mg simeprevir plus ribavirin.
The HELIX-1 trial is the first study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed between Janssen and Idenix in January 2013. A second trial (HELIX-2) of simeprevir, samatasvir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to commence in the second half of 2013.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292
About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Medivir AB and Janssen R&D Ireland for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
New drug applications were recently submitted for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C, and a Marketing Authorisation Application was submitted to the European Medicines Agency seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. The U.S. FDA has granted Priority Review to the New Drug Application.
Global phase III studies of simeprevir include PROMISE in adult patients who have relapsed after prior interferon-based treatment, QUEST-1 and QUEST-2 in treatment-naïve adult patients, and ATTAIN in prior null-responder adult patients. In parallel to these trials, phase III studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients.
Simeprevir is also being studied in phase II interferon-free trials with and without ribavirin in combination with:
· Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients;
· Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naïve and previous null-responder genotype 1 HCV patients; and
· Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 HCV patients.
In addition, Janssen Pharmaceuticals, Inc. has entered into a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a phase II study the safety and efficacy of an all-oral regimen of simeprevir and Vertex’s investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen Pharmaceuticals, Inc. is conducting a drug-drug interaction (DDI) study with simeprevir and VX-135.
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov
About Samatasvir (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers for up to 14 days duration and up to 100 mg in HCV-infected patients for up to 3 days duration.
There have been no treatment-emergent serious adverse events reported in the program. Samatasvir 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. For information about Idenix, please refer to www.idenix.com.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C virus worldwide, and about 350,000 people per year die from the disease. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.
Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
· Phase II HELIX-1 trial is first hepatitis C clinical study to commence through collaboration agreement between Janssen Pharmaceuticals Inc. and Idenix Pharmaceuticals Inc.
30-May-13
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that Idenix Pharmaceuticals Inc. has initiated a phase II clinical trial, called HELIX-1, evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, a once-daily protease inhibitor jointly developed by Medivir and Janssen R&D Ireland and samatasvir (IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor.
“Hepatitis C is a complex disease and there is a need for multiple treatment options. Future hepatitis C treatment will be interferon free and will consist of two to three direct acting antivirals (DAAs). We are pleased and looking forward to having simeprevir evaluated in this two-direct-acting antiviral phase II study”, said Charlotte Edenius, EVP Development, Medivir AB.
About the HELIX trial
The HELIX-1 trial is a 12-week, randomized, double-blind, parallel group study evaluating the safety and tolerability of simeprevir and samatasvir in addition to antiviral activity endpoints, with a target enrollment of 90 treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients.
Patients will be randomized equally across three treatment arms, receiving 50, 100, or 150 mg samatasvir once-daily for 12 weeks in combination with 150mg simeprevir plus ribavirin.
The HELIX-1 trial is the first study in HCV-infected patients to commence under a non-exclusive collaboration agreement signed between Janssen and Idenix in January 2013. A second trial (HELIX-2) of simeprevir, samatasvir and TMC647055, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen, is expected to commence in the second half of 2013.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292
About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Medivir AB and Janssen R&D Ireland for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
New drug applications were recently submitted for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C, and a Marketing Authorisation Application was submitted to the European Medicines Agency seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. The U.S. FDA has granted Priority Review to the New Drug Application.
Global phase III studies of simeprevir include PROMISE in adult patients who have relapsed after prior interferon-based treatment, QUEST-1 and QUEST-2 in treatment-naïve adult patients, and ATTAIN in prior null-responder adult patients. In parallel to these trials, phase III studies for simeprevir are ongoing in treatment-naïve and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients.
Simeprevir is also being studied in phase II interferon-free trials with and without ribavirin in combination with:
· Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naïve genotype 1a and 1b HCV patients;
· Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naïve and previous null-responder genotype 1 HCV patients; and
· Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 HCV patients.
In addition, Janssen Pharmaceuticals, Inc. has entered into a non-exclusive collaboration with Vertex Pharmaceuticals to evaluate in a phase II study the safety and efficacy of an all-oral regimen of simeprevir and Vertex’s investigational nucleotide analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first step, Janssen Pharmaceuticals, Inc. is conducting a drug-drug interaction (DDI) study with simeprevir and VX-135.
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov
About Samatasvir (IDX719)
Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers for up to 14 days duration and up to 100 mg in HCV-infected patients for up to 3 days duration.
There have been no treatment-emergent serious adverse events reported in the program. Samatasvir 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. For information about Idenix, please refer to www.idenix.com.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C virus worldwide, and about 350,000 people per year die from the disease. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
About Medivir
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.
Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com
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