BRISBANE, Calif., Dec. 10 InterMune, Inc.(Nasdaq: ITMN) today said that it will report top-line results in January 2009from its Phase 1b clinical trial of protease inhibitor ITMN-191 (R7227) incombination with standard-of-care Pegasys(R) (peginterferon alfa-2a) andCopegus(R) (ribavirin) for 14 days of treatment in treatment-naive patientschronically infected with the hepatitis C virus (HCV) genotype 1. ITMN-191 isbeing developed in collaboration with Roche.
Dan Welch, Chairman, Chief Executive Officer and President of InterMunesaid, "We now expect to report top-line data from six dosage cohorts; threecohorts each of twice-daily and three-times-daily regimens. Although the14-day triple combination study remains blinded at this time, and thus onlylimited inferences regarding safety can be made, adverse events to date havegenerally been mild to moderate and there have been no discontinuations duringthe study. Results from this study have guided the design of our plannedPhase 2 program which is anticipated to begin in the first half of 2009."
Mr. Welch continued, "In addition, we are pleased to report that the firstdosage cohort has been enrolled in the INFORM-1 study of ITMN-191 incombination with polymerase inhibitor R7128 (Roche/Pharmasset). INFORM-1 isthe first ever study to investigate the combined effects of two directantiviral agents in the absence of interferon in treatment-naive HCV patients.We expect results of this study to be reported at a major medical conferencein the first half of 2009."
Phase 1b Triple Combination Trial Design
The Phase 1b randomized, double-blind, placebo-controlled, 14-day triplecombination study in treatment-naive patients chronically infected with HCVgenotype 1 was designed to inform the dose selection and study design of thePhase 2 program. The study objectives are to assess the safety,pharmacokinetic and viral kinetic effects of ITMN-191 administered for 14 daysin combination with Pegasys and Copegus compared to the effects of Pegasys andCopegus alone. The protocol includes both twice-daily and three-times-dailyITMN-191 regimens starting with a total daily dose of 300mg.
InterMune is a biotechnology company focused on the research, developmentand commercialization of innovative therapies in pulmonology and hepatology.InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis(IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes the HCV protease inhibitor compound ITMN-191(referred to as R7227 at Roche) in Phase 1b, a second-generation HCV proteaseinhibitor research program, and a research program evaluating new targets inhepatology. For additional information about InterMune and its R&D pipeline,please visit http://www.intermune.com.
This news release contains forward-looking statements within the meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release, including without limitation the statements related toanticipated product development timelines. All forward-looking statements andother information included in this press release are based on informationavailable to InterMune as of the date hereof, and InterMune assumes noobligation to update any such forward-looking statements or information.InterMune's actual results could differ materially from those described inInterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, butare not limited to, those discussed in detail under the heading "Risk Factors"in InterMune's most recent annual report on Form 10-K filed with the SEC onMarch 14, 2008 (the "Form 10-K") and other periodic reports filed with theSEC, including the following: (i) risks related to the long, expensive anduncertain clinical development and regulatory process, including having nounexpected safety, toxicology, clinical or other issues or delays inanticipated timing of the regulatory approval process; (ii) risks related tofailure to achieve the clinical trial results required to commercialize ourproduct candidates; and (iii) risks related to timely patient enrollment andretention in clinical trials. The risks and other factors discussed aboveshould be considered only in connection with the fully discussed risks andother factors discussed in detail in the Form 10-K and InterMune's otherperiodic reports filed with the SEC, all of which are available viaInterMune's web site at http://www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
SOURCE InterMune, Inc.