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

e (SAD) Study in Healthy Volunteers (Poster #1871): ITMN-191 was safe and well tolerated when given as a single dose to healthy adults in a range of doses from 2mg to 1600mg. Adverse events were generally mild and transient and were similar between treatment groups, with the exception of a higher frequency of mild and transient diarrhea and abdominal pain in the ITMN-191 group at the highest tested dose (1600mg). The pharmacokinetics of ITMN-191 were linear over the dose range of 100mg to 800mg. Co-administration of ITMN-191 with food increased the expected trough and AUC by 40-50% compared with administration of ITMN-191 without food. This "food effect" enabled InterMune and Roche to explore a lower range of doses of ITMN-191 in subsequent clinical studies than was previously planned.

-- A Phase 1b Monotherapy Multiple-Ascending-Dose (MAD) Study in HCV Genotype 1 Patients (Poster #1847): ITMN-191 was administered as mono-therapy for 14 days to four cohorts of treatment-naive patients infected with HCV genotype 1. Multiple ascending doses were examined up to a total daily dose of 600mg. The safety and tolerability of ITMN-191 were excellent. Adverse events were generally mild and transient, with no evidence of clinically significant laboratory abnormalities or ECG changes. When ITMN-191 was administered every eight or twelve hours, viral kinetic results were very competitive with those of other direct antiviral compounds studied in similar experiments.

The MAD study also included one exploratory cohort of ITMN-191 given as mono-therapy for 14 days to strictly defined non-responders: HCV genotype 1 patients who had failed to achieve a 2.0 log10 reduction in HCV RNA with prior standard-of-care treatment, or who still had detectable HCV RNA after 24 weeks of treatment. At the one dose studied of 300mg given every 12 hours, ITMN-191 delivered a median reduction of HCV RNA at study day 14 of 2.5 log10. The results from this initial exploratory cohort in non
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