Idenix (IDIX) Reports Results from Two Phase IIb Studies of the Combination of Valopicitabine and Pegylated Interferon in Hepatitis C Genotype-1 Patients
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Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) announced results from two phase IIb studies of the novel combination of valopicitabine (NM283) and pegylated interferon alfa-2a in both treatment-naive and treatment- experienced patients infected with the genotype-1 strain of the hepatitis C virus (HCV). These data, as well as preclinical data on the active component of valopicitabine in combination with Schering Plough's investigational protease inhibitor boceprevir, will be presented at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL).
The first study, which was conducted at 23 sites in the United States, evaluated the safety and efficacy of various doses of valopicitabine plus pegylated interferon in 173 HCV genotype-1 infected, treatment-naive patients over 48 weeks. The primary endpoint of the study is sustained virologic response (SVR), defined as maintained viral clearance six months after treatment is stopped. At the end of the treatment period, which was 48 weeks, 53% of patients treated with 200 mg/day valopicitabine plus pegylated interferon achieved undetectable HCV levels by the TaqMan assay.
The second phase IIb clinical trial, which was conducted at 22 sites in the United States, evaluated various doses of valopicitabine in combination with pegylated interferon compared to pegylated interferon and ribavirin in 178 HCV genotype-1 infected, treatment-experienced patients for a treatment duration of up to 72 weeks. The primary endpoint of the study was SVR, defined as maintained viral clearance six months after treatment is stopped.
A separate study presented at EASL evaluated the combined antiviral effect of the active component of valopicitabine, NM107, and SCH 503034, Schering Plough's investigational protease inhibitor currently in phase II trials, using cell culture replicon studies. The in vitro results demonstrated that the combination of these two agents provided additive antiviral activity compared to either agent used alone, with no cross resistance.
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