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ITMN: InterMune Announces Start of 14-Day Triple Combination Study of ITMN-191 in Patients With Chronic Hepatitis C
Thursday May 29, 8:00 am ET
- Fifth cohort of MAD study supports continued development in treatment-experienced patients -

BRISBANE, Calif., May 29 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that it has begun dosing in its Phase 1b clinical trial evaluating ITMN-191, designated R7227 at Roche (SWX: ROG - News), in combination with Pegasys® (pegylated interferon alpha-2a) and Copegus® (ribavirin) in treatment-naive patients infected with chronic hepatitis C virus (HCV) genotype 1 infection.

InterMune also reported that results from the only cohort of treatment-experienced patients in its Phase 1b multiple-ascending-dose (MAD) clinical trial of ITMN-191 given as monotherapy support continued development of the compound in treatment-experienced patients. InterMune expects to submit results from all dose cohorts in the MAD study for possible presentation at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

Dan Welch, Chairman and Chief Executive Officer of InterMune, said, "After having recently announced excellent safety and very competitive reductions in serum HCV RNA levels following monotherapy of ITMN-191 in treatment-naive chronic hepatitis C patients, we are pleased to announce the start of our very important 14-day triple combination study of ITMN-191 plus Pegasys and ribavirin, also in treatment-naive patients." He continued, "We are also pleased to report that ITMN-191 given as monotherapy to treatment-experienced patients demonstrated a safety profile and viral kinetic performance that support the continued development of ITMN-191 in this patient population. Based on the monotherapy results to date, we and our partner Roche are planning the development of ITMN-191 in combination with various antiviral compounds, including other small molecule direct antivirals, in both treatment-naive and treatment-experienced patients."

Phase 1b Triple Combination Trial Design

The Phase 1b placebo-controlled, triple combination study is anticipated to enroll up to approximately 50 treatment-naïve patients chronically infected with HCV genotype 1. The study will assess the effects of multiple doses and regimens of ITMN-191 given in combination with pegylated interferon alpha-2a (Pegasys®) and ribavirin on safety, efficacy, pharmacokinetics and viral kinetics compared to the effects in patients treated only with pegylated interferon alpha-2a and ribavirin.

All patients will receive standard treatment with pegylated interferon alfa-2a and ribavirin. In addition to this standard treatment, patients will be randomized to receive either ITMN-191 or placebo, administered with a meal for a period of 14 days, and a single dose on Study Day 15.

Up to five cohorts of patients will be enrolled, exploring total daily doses starting at 300mg. Both twice daily and three-times-daily regimens will be studied to collect data on the safety, pharmacokinetic and viral kinetic effects of ITMN-191 when given with Pegasys and ribavirin.

InterMune expects to announce top-line results from the triple combination study during the fourth quarter of this year.

Publication Plans for ITMN-191

InterMune intends to submit several abstracts regarding ITMN-191 for possible presentation at the 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), scheduled for October 31 - November 4, 2008 in San Francisco. Among the abstracts submitted will be the clinical experience with ITMN-191 to date including, but not limited to, the results of the single-ascending-dose (SAD) study, the multiple-ascending-dose (MAD) monotherapy study of ITMN-191 as well as in-vitro results of ITMN-191 in combination with various direct antiviral compounds.


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