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InterMune Reports Second Quarter 2009 Financial Results and Business Highlights
Date:8/6/2009

other HCV protease inhibitor in development. In an initial Phase 1 study of ITMN-191 co-administered with low dose ritonavir in healthy volunteers, important PK parameters showed marked improvement. Clearance of the compound was dramatically reduced, resulting in significant increases in AUC and drug concentrations at later times. There were no remarkable safety findings. The potential product and patient benefits of the ritonavir boosting strategy are less frequent administration and a lower dose or pill burden for ITMN-191, which may enhance the possibility of co-formulating ITMN-191 with other direct antiviral agents.
  • At the Annual Meeting of the European Association for the Study of the Liver (EASL) in late April, results were reported from a 14-day, Phase 1b study of ITMN-191 in combination with Pegasys and ribavirin.
    • After 14 days of triple combination therapy, the median change in HCV RNA from baseline exceeded 5 log10 in five of the six dosage cohorts, and was -5.4 log10 and -5.7 log10 in the best performing q12h and q8h cohorts, respectively.
    • There was no evidence of viral rebound during ITMN-191 treatment in any cohort.
    • ITMN-191 plus standard-of-care therapy was safe and generally well tolerated.
  • Also at the EASL meeting in late April, InterMune, Roche and Pharmasset, Inc. reported initial results from the novel Phase 1 INFORM-1 clinical trial evaluating ITMN-191 in combination with nucleoside polymerase inhibitor R7128, but no interferon or ribavirin, in patients with HCV infection. Data from the first four dosage cohorts of the study demonstrated that the combination resulted in sustained viral load reductions over the dosing period in all cohorts. The combination was well tolerated over 14 days, with no treatment-related serious adverse events (SAEs), dose reductions or discontinuations. There were no drug-drug interactions between the
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  • SOURCE InterMune, Inc.
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