InterMune, Inc announced top-line results from the planned Week 12 interim analysis of the phase-2b randomized, partially-blind study evaluating the hepatitis C virus (HCV) protease inhibitor danoprevir (also known as RG7227 and ITMN-191), administered for 12 weeks in combination with Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin), compared with placebo for the same duration plus Pegasys and Copegus. The virologic response results are summarized in the following table:

Dan Welch, chairman, chief executive officer and President of InterMune, said, "The RVR and cEVR results reported today are among the very best reported by any DAA compound to date, reinforcing our view that danoprevir may potentially play a meaningful role in the treatment of HCV patients. With Roche, we are now focused on making the critical dose and regimen selection decision for future development plans for ritonavir-boosted danoprevir, an approach that appears to deliver strong efficacy and offer attractive advantages of dosing convenience and increased safety margin."

Frank Duff, head of Roche's Clinical Development for Virology, said, "Future development of danoprevir is expected to be conducted in combination with ritonavir at total daily doses that are 10-25% of those examined in this study. The pharmacokinetics/pharmacodynamics and safety data from this large, well-controlled study, in addition to other data being collected, will be very helpful in our efforts to choose the optimal dose and regimen for the ritonavir-boosted danoprevir global development programme, including the all-oral, direct-acting antiviral INFORM component of the programme."

InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.