InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
- Phase 2 study expected to begin in 1H 2009 -
BRISBANE, Calif., December 10, 2008 /PRNewswire-FirstCall/ -- InterMune, Inc. today said that it will report top-line results in January 2009 from its Phase 1b clinical trial of protease inhibitor ITMN-191 (R7227) in combination with standard-of-care Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) for 14 days of treatment in treatment-naive patients chronically infected with the hepatitis C virus (HCV) genotype 1. ITMN-191 is being developed in collaboration with Roche.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We now expect to report top-line data from six dosage cohorts; three cohorts each of twice-daily and three-times-daily regimens. Although the 14-day triple combination study remains blinded at this time, and thus only limited inferences regarding safety can be made, adverse events to date have generally been mild to moderate and there have been no discontinuations during the study. Results from this study have guided the design of our planned Phase 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 first dosage cohort has been enrolled in the INFORM-1 study of ITMN-191 in combination with polymerase inhibitor R7128 (Roche/Pharmasset). INFORM-1 is the first ever study to investigate the combined effects of two direct antiviral agents in the absence of interferon in treatment-naive HCV patients. We expect results of this study to be reported at a major medical conference in the first half of 2009."
Phase 1b Triple Combination Trial Design
The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple combination study in treatment-naive patients chronically infected with HCV genotype 1 was designed to inform the dose selection and study design of the Phase 2 program. The study objectives are to assess the safety, pharmacokinetic and viral kinetic effects of ITMN-191 administered for 14 days in combination with Pegasys and Copegus compared to the effects of Pegasys and Copegus alone. The protocol includes both twice-daily and three-times-daily ITMN-191 regimens starting with a total daily dose of 300mg.
InterMune is a biotechnology company focused on the research, development and 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 portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating new targets in hepatology. 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 meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are 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 on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, firstname.lastname@example.org
Web site: http://www.intermune.com/
Ticker Symbol: (NASDAQ-NMS:ITMN)
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Posted: December 2008