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InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)
Date:4/24/2009

otality of the viral kinetic data, the q12h and q8h regimens delivered very convincing results and appeared to perform very comparably in this 14-day study. The safety and tolerability profile of ITMN-191 in both the earlier monotherapy study and in the present triple combination study was also encouraging, as no issues of concern were observed. We look forward to the Phase 2b study to determine if the very promising profile of ITMN-191 observed will be confirmed."

InterMune noted that a Phase 2b triple combination trial of ITMN-191 is planned for initiation in the summer of 2009. A Phase 1 trial of ITMN-191 and polymerase inhibitor R7128 (INFORM-1 Study) is currently underway.

Steven Porter, M.D., Ph.D., Chief Medical Officer of InterMune, said, "The Phase 1b triple combination study was designed to inform the dose selection and study design of the ITMN-191 Phase 2 program. The Phase 2b program will study both q12h regimens (600mg and 900mg q12h) and a q8h regimen (300mg q8h) and both 12-week and 24-week treatment durations. We believe that the viral kinetic and safety results reported today provide evidence that ITMN-191 has the potential to deliver superior sustained virologic response (SVR) rates in patients chronically infected with the hepatitis C virus."

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


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SOURCE InterMune, Inc.
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4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
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