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InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
Date:4/1/2008

ted by Roche.

Regarding formulation, InterMune reported that Roche has completed development of the tablet formulation of ITMN-191 that will be used in the Phase 2 program. Given the relatively low total daily dose of ITMN-191 required to show substantial antiviral activity, Roche has begun work on a modified-release formulation of ITMN-191 with the goal of optimizing the delivery of ITMN-191, potentially to a once per day administration.

Phase 1b (MAD) Trial Design

The ongoing Phase 1b placebo-controlled study is designed to assess the effect of multiple doses of ITMN-191 given as monotherapy on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability. A principal goal of the MAD study is to help choose the range of doses of ITMN-191 that when administered in combination with Pegasys(R) (pegylated interferon alfa-2a) and Copegus(R) (ribavirin) would likely offer the optimal protease inhibitor-based triple combination regimen in terms of efficacy, safety and tolerability. The Phase 1b study also will inform the design of future combination studies using small molecule HCV compounds of different mechanisms of action.

In the Phase 1b study, four cohorts of treatment-nave patients received ITMN-191 in a gelatin capsule every 12 hours or every 8 hours with food for a period of 14 days. In addition, a single cohort of treatment-experienced chronic hepatitis C patients infected with HCV genotype 1 will begin dosing next week at the 300mg every 12 hour dose level.

Conference Call and Webcast Details

InterMune will host a conference call today at 8:30 a.m. EDT to discuss the preliminary Phase 1b clinical trial results of ITMN-191 and the Program Update. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID #41908166. A replay of the webcast and teleconference will be available approximately three hours after the call. '/>"/>

SOURCE InterMune, Inc.
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