Idenix Pharmaceuticals (IDIX)

[nivasvs]

Phase II study for IDX184 initiated

Idenix Pharmaceuticals, Inc. Initiates Phase II Clinical Trial Of IDX184 In Combination With Pegylated Interferon And Ribavirin For Treatment Of Hepatitis C Virus (HCV)
8:02am EST

Idenix Pharmaceuticals, Inc. announced that it has initiated a Phase II clinical trial evaluating IDX184, a liver-targeted nucleotide prodrug candidate for the treatment of HCV, in combination with pegylated interferon and ribavirin, in treatment-naive hepatitis C genotype 1-infected patients. Antiviral activity, safety and tolerability of the triple combination will be assessed at 14 days. Patients will continue on treatment with pegylated interferon and ribavirin for 14 days and Rapid Viral Response (RVR), the proportion of patients with undetectable virus at week 4, will be determined at Day 28.The clinical trial is a Phase II, randomized, double-blind, placebo-controlled, sequential dose-escalation study evaluating the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve HCV genotype 1-infected patients. Patients will receive a daily dose of IDX184 or placebo plus pegylated interferon and ribavirin for 14 days and then continue on pegylated interferon and ribavirin for an additional 14 days. Antiviral activity will be assessed at the 14-day and 28-day timepoints. All patients in the study will have the option to continue pegylated interferon and ribavirin for up to 48 weeks. Four doses of IDX184 ranging from 50 to 200 mg per day will be evaluated. Each cohort of the study will evaluate twenty patients randomized 16 to IDX184 and 4 to placebo.