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Roche and InterMune Initiate Phase 2b Clinical Trial of RG7227/ ITMN-191 in Patients With Chronic Hepatitis C
Date:8/19/2009

e objective of the Phase 2b randomized, double-blind, placebo-controlled study is to further characterize the safety, tolerability, and antiviral effects of RG7227/ 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 RG7227/ 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 RG7227/ 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 RG7227/ 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.

RG7227/ ITMN-191 - Next Steps in Development Program

Roche and InterMune will also initiate in the third quarter a Phase 1 trial combining RG7227/ ITMN-191 with low dose ritonavir to examine the virologic effect of ritonavir-boosted RG7227/ ITMN-191 in once-daily and twice-daily regimens in combination with standard dosing of PEGASYS and COPEGUS in patients chronically infected with HCV genotype 1.

This study builds on promising drug-drug interaction data recently generated in healthy volunteers; a low dose of ritonavir significantly
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SOURCE InterMune, Inc.
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