- Q12h and Q8h Regimens Deliver Robust Antiviral Effects and Strong Safety Profile -
- Phase2b Study Anticipated to Begin in Q2 2009 -
- Conference call today at 8:30 a.m. EST -
BRISBANE, Calif., Jan. 12 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today reported top-line results from all six completed dosage cohorts of its Phase 1b clinical trial of ITMN-191 (R7227) in combination with standard-of-care Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) for 14 days of treatment in hepatitis C virus (HCV) treatment-naive patients infected with HCV genotype 1. ITMN-191 is being developed in collaboration with Roche (SWX: ROG). Viral kinetic performance and safety results were reported for three cohorts each of ITMN-191 given every 12 hours (q12h) and every eight hours (q8h).
Viral Kinetic Performance
After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 logs in five of the six cohorts and was -5.4 log and -5.7 log in the best performing q12h and q8h cohorts, respectively. Considering all cohorts, HCV RNA was below the limit of quantification in nearly three-quarters (71%, or 32 of 45) of patients who received treatment with ITMN-191 after only 14 days of treatment. In all q12h and q8h cohorts, reductions in HCV RNA occurred rapidly and there was no evidence of viral rebound during ITMN-191 treatment.
Safety and Tolerability Profile
ITMN-191 was generally safe and well tolerated. There were no serious adverse events (SAE) or Grade 4 adverse events (AEs) during treatment with ITMN-191. AEs reported during study treatment (ITMN-191 or placebo) were predominantly mild to moderate in severity, typically consistent with the well-described AE profile of standard of care
|SOURCE InterMune, Inc.|
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