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InterMune to Present Four Abstracts on HCV Protease Inhibitor ITMN-191 at the AASLD Meeting
Date:9/24/2008

-responders encouraged InterMune and Roche to continue their plans to aggressively study ITMN-191 in this difficult to treat population and provided an important insight to the range of doses to explore in future studies.

-- Pharmacokinetic (pk) and Pharmacodynamic (pd) Results in the Phase 1b MAD Study (Poster #1861): ITMN-191 was intentionally designed to achieve a high liver-to-plasma ratio in HCV patients in order to reduce any potential side effects associated with systemic circulation of drug. Poster #1861 shows that the strong viral kinetic results reported in abstract #1847 were associated with very low plasma concentrations, achieving the key objective of a high liver-to-plasma ratio in patients infected with HCV. The pharmacokinetics of ITMN-191 in mono-therapy were more than dose proportional at higher doses.

Results of In Vitro Combinations of ITMN-191 plus direct anti-virals in HCV models

-- Two Experiments of the Combination of ITMN-191 with HCV Polymerase Inhibitors R7128 and R1626 (Poster #1885): ITMN-191 was combined separately with two polymerase inhibitors, R7128 (Roche/Pharmasset) and R1626 (Roche) in two assays. One assay modeled HCV replication (14-day replicon clearance assay) and the other assay modeled viral resistance (a 3-week colony formation assay model). The combination of ITMN-191 with the active moeity of either R7128 or R1626 resulted in significantly enhanced clearance of the HCV replicon and reduced or suppressed the emergence of drug-resistant viral variants.

This work was carried out in anticipation of future clinical studies using ITMN-191 with either R7128 or R1626, and demonstrates that such combinations would likely result in significantly greater antiviral activity than has been observed with any of these agents in previous monotherapy trials.

Current Development of ITMN-191

Based on the encouraging results reported in the above studies, in late May 2008 InterMune initiated an ongoin
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