Idenix Pharmaceuticals (Idenix) has initiated a phase II randomised, double-blind, placebo-controlled, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naive HCV genotype 1-infected patients.
Patients are expected to 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. 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 200mg per day will be evaluated.
The company said that each cohort of the study will evaluate 20 patients randomised 16 to IDX184 and 4 to placebo. This study is being conducted at multiple centers in the US and Argentina.
Douglas Mayers, chief medical officer of Idenix, said: “IDX184 was well tolerated and exhibited favorable antiviral activity in the initial 3-day, proof-of-concept study. We look forward to evaluating IDX184 over a longer treatment period and as a component of combination therapy. This trial will also help us determine the optimal doses for broader clinical development.”