Phase 1b Triple Combination Trial Design
The Phase 1b placebo-controlled, triple combination study is anticipated to enroll up to approximately 50 treatment-nave patients chronically infected with HCV genotype 1. The study will assess the effects of multiple doses and regimens of ITMN-191 given in combination with pegylated interferon alpha-2a (Pegasys(R)) and ribavirin on safety, efficacy, pharmacokinetics and viral kinetics compared to the effects in patients treated only with pegylated interferon alpha-2a and ribavirin.
All patients will receive standard treatment with pegylated interferon alfa-2a and ribavirin. In addition to this standard treatment, patients will be randomized to receive either ITMN-191 or placebo, administered with a meal for a period of 14 days, and a single dose on Study Day 15.
Up to five cohorts of patients will be enrolled, exploring total daily doses starting at 300mg. Both twice daily and three-times-daily regimens will be studied to collect data on the safety, pharmacokinetic and viral kinetic effects of ITMN-191 when given with Pegasys and ribavirin.
InterMune expects to announce top-line results from the triple combination study during the fourth quarter of this year.
Publication Plans for ITMN-191
InterMune intends to submit several abstracts regarding ITMN-191 for
possible presentation at the 59th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD), scheduled for October
31 - November 4, 2008 in San Francisco. Among the abstracts submitted will
be the clinical experience with ITMN-191 to date including, but not limited
to, the results of the single-ascending-dose (SAD) study, the
multiple-ascending-dose (MAD) monotherapy study of ITMN-191 as well as
in-vitro results of ITMN-191 i
|SOURCE InterMune, Inc.|
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