Janssen to Start a Phase IIb Study/Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C

Study identifier: NCT02765490.
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) or AL-335 and ODV in the Treatment of Chronic Hepatitis C Infection

Janssen; Phase IIb Study of Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C

Medivir AB (STO:MVIRB) today announces that Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies (Janssen), has decided to initiate a phase IIb study to investigate the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naïve and treatment-experienced patients with chronic Hepatitis C Virus (HCV) genotype 1-6 infection, with and without cirrhosis.
   

This global phase IIb study is a randomized, open-label, four-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A protease inhibitor. Approximately 400 patients will be randomized to one of four treatment arms and receive once daily treatment for a duration of six or eight weeks. Patients in two of the four arms will receive AL-335, odalasvir and simeprevir, a compound jointly developed by Janssen Sciences Ireland UC and Medivir AB, while patients in the other two arms will receive only AL-335 and odalasvir. The primary endpoint of the study is the percentage of chronic HCV-infected subjects who achieve a sustained virologic response 12 weeks after the end of treatment (SVR12). The study is intended to start in June 2016 and the estimated date for completion is July 2017.

Further information about the study can be found at www.clinicaltrials.gov.

Study identifier: NCT02765490.

   

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 9.15 CET on 11 May 2016.

About Simeprevir (OLYSIO®)

   

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. In November 2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

About Medivir    

Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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Janssen Initiates Phase 2a HCV Study: AL-335, Odalasvir (ACH-3102), and Simeprevir for Genotype 1

Achillion Announces That Janssen Has Initiated a Phase 2a Study to Evaluate the Combination of AL-335, Odalasvir (ACH-3102), and Simeprevir for the Treatment of Genotype 1 Chronic HCV

By GlobeNewswire, October 16, 2015, 06:05:00 AM EDT

Once Daily Triple Direct-Acting Antiviral Regimen Will be Evaluated for Treatment Durations of Four, Six or Eight Weeks

NEW HAVEN, Conn., Oct. 16, 2015 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc.(Nasdaq:ACHN) announced today that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has initiated treatment in a phase 2a clinical trial to evaluate the safety, pharmacokinetics and efficacy of AL-335, odalasvir (also known as ACH-3102), and simeprevir in treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection.

This phase 2a study is a randomized, open-label, three-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor, and simeprevir, an HCV NS3/4A protease inhibitor. Patients will be randomized to one of three treatment arms and receive once daily treatment for a duration of four, six or eight weeks. The primary objective of the study is to establish the safety of the treatment regimen with secondary endpoints consisting of pharmacokinetics, the proportion of subjects achieving sustained viral response (SVR), and the effect on the viral resistance profile after treatment. The study is expected to enroll approximately 60 patients across the three treatment arms.

As previously announced on May 19, 2015, Achillion has granted Janssen an exclusive, worldwide license to develop and, upon regulatory approval, commercialize HCV products and regimens containing one or more of Achillion's HCV assets which include odalasvir (ACH-3102), ACH-3422, and sovaprevir.

Further information about the study can be found at www.clinicaltrials.gov. Study identifier: NCT02569710.

Read more: http://www.nasdaq.com/press-release/achillion-announces-that-janssen-has-initiated-a-phase-2a-study-to-evaluate-the-combination-of-20151016-00108#ixzz3okSzohFn

Hepatitis C - Janssen starts a study to evaluate simeprevir and odalasvir on AL-335 pharmacokinetics

Medivir announces that Janssen has started a phase I study to evaluate the effect of simeprevir and odalasvir on AL-335 pharmacokinetics

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has started a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102), on the pharmacokinetics of AL-335 in healthy volunteers.

This phase I study is an open-label, two-group study of simeprevir, odalasvir, a hepatitis C virus (HCV) NS5A inhibitor, and of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective of the study is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers.

Approximately 150 million people are chronically infected with HCV globally*. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However, combinations of antiviral agents, including e.g. a protease inhibitor such as simeprevir, have shown the potential to be curative and convenient regimens for patients infected with HCV.

Further information about the study can be found at www.clinicaltrials.gov

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0)725-480 580.

Medivir is required under the Securities Markets Act to make the information in this press release public.
The information was submitted for publication at 8.30 CET on 3 August 2015.

About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. In November 2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May 2014, it was granted marketing authorisation by the European Commission. Subsequent marketing authorisations have followed in several other countries around the world. Indications vary by market.

About Medivir
Medivir is a research based pharmaceutical company with a research focus on infectious diseases and oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a growing portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

*http://www.who.int/mediacentre/factsheets/fs164/en/