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news.InterMune has started dosing in its Phase Ib clinical trial evaluating ITMN-191, designated R7227 at Roche, in combination with Pegasys and Copegus in treatment-naive patients infected with chronic hepatitis C virus genotype 1 infection.
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The Phase Ib placebo-controlled, triple combination study is anticipated to enroll up to approximately 50 treatment-naïve patients chronically infected with hepatitis C virus (HCV) genotype 1. The study will assess the effects of multiple doses and regimens of ITMN-191 given in combination with pegylated interferon alpha-2a (Pegasys) and ribavirin on safety, efficacy, pharmacokinetics and viral kinetics compared to the effects in patients treated only with pegylated interferon alpha-2a and ribavirin.
All patients will receive standard treatment with pegylated interferon alfa-2a and ribavirin. In addition to this standard treatment, patients will be randomized to receive either ITMN-191 or placebo, administered with a meal for a period of 14 days, and a single dose on study day 15. Up to five cohorts of patients will be enrolled, exploring total daily doses starting at 300mg.
Both twice daily and three-times-daily regimens will be studied to collect data on the safety, pharmacokinetic and viral kinetic effects of ITMN-191 when given with Pegasys and ribavirin. InterMune expects to announce top-line results from the triple combination study during the fourth quarter of 2008.