InterMune Reports Third Quarter 2009 Financial Results and Business ...(safe and generally well tolerated. ....),Health

ITMN-191 (RG7227)

• On November 3, results of INFORM-1 were presented at the meeting of the American Association for the Study of the Liver (AASLD). INFORM-1 is a Phase 1 study of two direct-acting antiviral (DAA) compounds administered without interferon or ribavirin for the treatment of patients chronically infected with HCV. The study combined the oral NS3 protease inhibitor ITMN-191 and the oral nucleoside analog polymerase inhibitor RG7128. The results announced at AASLD focused on the recently completed final three cohorts of INFORM-1, consisting of higher-dose, twice-daily regimens:
  • The full dose combination of RG7128 1000mg and RG7227 900mg administered twice-daily without pegylated interferon or ribavirin for 13 days resulted in 88% of HCV-positive treatment-naive patients achieving HCV RNA below the lower limit of quantification (LLOQ; <43 IU/mL), and 63% of patients having HCV RNA below the lower limit of detection (LLOD; <15 IU/mL).
  • The same regimen in "null responders" resulted in 50% of patients with HCV RNA below LLOQ and 25% of patients with HCV RNA below LLOD.
  • No treatment-emergent resistance to RG7227 or RG7128 was observed in the study.
  • The all-oral, interferon-free combination showed promising safety and tolerability. No treatment-related serious adverse events (SAEs), dose reductions or discontinuations were reported in any patient in INFORM-1, including previously reported lower dose cohorts. The most commonly reported adverse events (AEs) were headache, nausea and diarrhea and these had a similar incidence to previously reported lower-dose cohorts.
• Enrollment began in August for the company's Phase 2b study of ITMN-191 in combination with PEGASYS® (pegylated interferon) and COPEGUS® (ribavirin), the current standard of care in HCV. The Phase 2b trial will study both twice-daily (600mg a
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