InterMune (ITMN) Updates on Phase 2b of Danoprevir in Combination with PEGASYS and COPEGUS

InterMune (ITMN) Updates on Phase 2b of Danoprevir in Combination with PEGASYS and COPEGUS
April 14, 2010 7:09 AM EDT

InterMune, Inc. (NASDAQ: today announced top-line results from the planned Week 12 week 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.

Dan Welch, Chairman, Chied 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, M.D., 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 program, including the all-oral, direct-acting antiviral INFORM component of the program."

Safety and Tolerability

The analysis of the safety data is preliminary in nature and additional evaluation is ongoing. In the interim safety analysis, serious adverse events (SAEs) were generally balanced across all four treatment groups. The incidence of treatment-emergent Grade 4 (>10x ULN ALT elevations was 0%, 1%, 6% and 0% in the 300 mg three-times daily, 600 mg twice daily, 900 mg twice daily and placebo groups, respectively. In the danoprevir treatment groups, these elevations occurred generally between weeks 6-8 or later and were reversible after discontinuation of danoprevir. Dosing of the 900 mg arm was stopped based on this safety signal. Treatment-emergent Grade 3 or Grade 4 neutropenia was reported in 24%, 25%, 31% and 16% of patients in the 300 mg three-times daily, 600 mg twice daily, 900 mg twice daily and placebo groups, respectively. The incidence of rash and anemia was comparable across all treatment groups, including the placebo group (SOC + placebo).