Roche and InterMune Initiate Phase 2b Clinical Trial of R7227/ ITMN-191 in Patients with Chronic Hepatitis C
News Aug 24, 2009
Roche and InterMune, Inc. have announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, R7227/ ITMN 191, in combination with PEGASYS® (pegylated interferon alfa 2a) and COPEGUS® (ribavirin).
The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of R7227/ ITMN 191, for a treatment duration of up to 24 weeks.
R7227/ ITMN 191 is being developed in partnership by Roche and InterMune. Initiation of the Phase 2b trial triggered a $20 million event payment from Roche to InterMune under the companies’ collaboration agreement.
The objective of the Phase 2b randomized, double-blind, placebo-controlled study is to further characterize the safety, tolerability, and antiviral effects of R7227/ ITMN-191 in triple combination, compared with standard of care (PEGASYS plus COPEGUS).
The two-part study will evaluate treatment regimens of both 12 and 24 weeks. In Part 1 of the study, approximately 210 patients will be randomized to one of four study arms – three of which will receive a 12-week regimen of R7227/ ITMN-191 at either 300 mg every 8 hours, 600 mg every 12 hours or 900 mg every 12 hours, in combination with PEGASYS and COPEGUS, followed by 12 weeks of therapy with PEGASYS and COPEGUS. The fourth group will be a control arm receiving PEGASYS and COPEGUS dosed for 48 weeks.
Part 2 of the study, which is expected to begin in the first quarter of 2010, will further evaluate R7227/ ITMN-191 in a 24-week triple combination regimen with PEGASYS and COPEGUS. Approximately 90 patients will be randomized to one of two study arms in Part 2, either a 24- week regimen of R7227/ ITMN-191 in combination with PEGASYS and COPEGUS, or a control arm of PEGASYS and COPEGUS dosed for 48 weeks. Dose selection for Part 2 will be informed by week 4 results generated in Part 1.
RVR results from Part 1 of the study are expected in the first quarter of 2010.