Roche, InterMune and Pharmasset Announce Initiation of INFORM-1
News Nov 12, 2008
Roche, InterMune, Inc. and Pharmasset announced that the first patients have been dosed in a clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial (run in centers in Australia and New Zealand) is the first to investigate the combination of two oral antiviral molecules in the absence of interferon.
The initial study will evaluate the safety and combined antiviral activity of R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase inhibitor, in 14 days of combination therapy in treatment-naive patients infected with HCV genotype 1.
This direct antiviral combination study represents an important first step in evaluating the therapeutic potential of an all-oral, interferon-free combination treatment for HCV. Roche is positioned to develop all-oral combination studies in HCV through its collaborations with InterMune and Pharmasset, which provide access to both protease and polymerase inhibitors, respectively.
With InterMune, Roche is developing R7227, an HCV protease inhibitor compound to be used in combination with PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin), the current standard of care (SOC).
Concurrently with Pharmasset, Roche is developing R7128, an HCV RNA polymerase inhibitor, also for therapy in combination with PEGASYS® and COPEGUS®. Both of these molecules have successfully completed Phase 1 monotherapy studies, have been dosed in combination with PEGASYS® and COPEGUS® and both have individually demonstrated their efficacy against HCV.
Current standard of care for HCV comprises pegylated interferon plus ribavirin, for a duration that is dependent upon factors such as genotype of the virus. For the most difficult to treat genotype 1 virus, a 48-week treatment course generally results in sustained viral response in about 50% of patients.
PEGASYS® and COPEGUS® are the current foundation of HCV treatment and the preferred pegylated interferon therapy of choice for most HCV antiviral agents in development.