New Study Will Test Simeprevir plus Daclatasvir for Previously Untreated Hepatitis C

Researchers will soon begin testing an interferon-free dual oral regimen of simeprevir (better known as TMC435) plus daclatasvir (formerly BMS-790052) for treatment-naive genotype 1 chronic hepatitis C patients, co-developer Medivir announced last week.

The advent of direct-acting antivirals has ushered in a new era of hepatitis C treatment. While the first direct-acting drugs are being used in combination with pegylated interferon and ribavirin, combining agents that target different steps of the hepatitis C virus (HCV) lifecycle offers the prospect of all-oral regimens.

TMC435 is a potent once-daily HCV NS3/4A protease inhibitor being developed jointly by Medivir and Janssen/Tibotec. Early studies showed it has potent activity against HCV genotype 1 and a favorable safety profile, and it improves sustained response rates when added to standard therapy.Bristol-Myers Squibb's daclatasvir is a promising NS5A replication complex inhibitor;the function of NS5A is not fully understood, but it appears to play an important role in viral replication.

Below is an edited excerpt from the recent Medivir press release describing the new study.

Medivir Announces an Interferon-free Phase II Combination Trial with TMC435 and Daclatasvir to Commence Shortly

The phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naive or previous null responder patients with HCV genotype 1a and 1b.

The study will include approximately 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without ribavirin, in four different cohorts for 12 or 24 weeks of treatment.

Stockholm, Sweden -- Medivir AB (OMX:MVIR), the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that a phase II combination study with the investigational compound TMC435 and Bristol-Myers Squibb’s investigational compound daclatasvir will start in July. This study is part of the clinical collaboration agreement between Janssen R&D Ireland and Bristol-Myers Squibb Company (NYSE:BMY) announced on 2 December 2011 and on 18 April 2012.

TMC435 and daclatasvir (BMS-790052)

TMC435, a once daily potent NS3/4A protease inhibitor (PI) in phase III clinical development for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection, will be investigated in an interferon free phase II trial in combination with Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, daclatasvir (BMS-790052), also in phase III development.

The purpose of this study is to assess the efficacy and safety of TMC435 and daclatasvir in combination with or without ribavirin in chronic genotype-1 hepatitis C infected patients who are treatment-naive or null responders to previous peginterferon alfa/ribavirin therapy.

Study design

In this open label phase II study the potential to achieve sustained viral response (SVR), 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naïve and null responder patients infected with HCV genotype 1a and 1b will be evaluated. Patients with advanced liver disease (F3/F4) will be allowed up to approximately 35% of the total treated population.

Cohort one and two will include patients with genotype 1b where TMC435 and daclatasvir will be dosed with or without ribavirin for 12 weeks with a 36 weeks follow-up or for 24 weeks with a 24 weeks follow-up.

Cohort three and four will include patients with genotype 1a where TMC435, daclatasvir and Ribavirin will be dosed for 12 or 24 weeks with a 24 weeks post treatment follow-up.

For additional information from these recently updated studies, please see www.clinicaltrials.gov.

About Medivir

Medivir is an emerging research-based pharmaceutical company focused on the development of high-value treatments for 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 TMC435, a novel protease inhibitor in phase III clinical development for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals. In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialization of TMC435 in the Nordic markets, once approved. Medivir’s first product, the unique cold sore product Xerese/Xerclear, is launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDou in Europe, Japan and Russia.

For more information about Medivir, please visit the Company’s website: www.medivir.com.

7/6/12

Source

Medivir AB. Medivir Announces an Interferon-free Phase II Combination Trial with TMC435 and Daclatasvir to Commence Shortly. Press release. June 29, 2012.