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InterMune Reports Third Quarter 2009 Financial Results and Business Highlights
Date:11/5/2009

safe and generally well tolerated.

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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Related medicine technology :

1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
2. InterMune Announces Start of Phase 1b Trial of ITMN-191
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
5. InterMune Announces Progress on Pirfenidone in IPF
6. InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA
7. InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
8. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
9. InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
10. InterMune to Conduct Conference Call and Webcast to Discuss Results of Triple Combination Study of ITMN-191
11. InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3
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