SAN FRANCISCO, Calif., Nov. 14 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today the presentation of studies examining the potency of its two small molecule hepatitis C virus (HCV) protease inhibitors, ITMN A and ITMN B, against drug resistant strains of HCV. The pre-clinical findings were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco this week.
“These rationally designed compounds have already demonstrated high potency, favorable pharmacokinetics and promising tolerability in animal models, and these findings support our plans to launch a full development program to assess the potential benefit in humans. The ability of the compounds to show activity against mutant HCV strains indicates compounds such as these may be developed to increase treatment options of patients who are infected with drug-resistant HCV,” said Dan Welch, President and CEO of InterMune. “These data support our dedication to becoming a market leader in the development of small molecule therapeutics that target the HCV protease.”
ITMN A and B, Novel Inhibitors of the HCV NS3/4 Protease Retain Their Potency Against VX-950 and BILN-2061 Resistant NS3/4 Protease Mutants and an IFN-alpha-2a Resistant HCV Replicon
Results from this study point to the potential promise of ITMN A and ITMN B to treat drug-resistant strains of HCV. Researchers demonstrated in vitro activity of ITMN A and ITMN B against mutant forms of the HCV NS3/4 protease, which are resistant to two other investigational compounds designed to inhibit it, VX-950 and BILN-2061, developed by Vertex Pharmaceuticals and Boehringer Ingelheim respectively. ITMN A and ITMN B were each approximately 1,000-fold more potent than VX-950 against the VX-950 resistant protease mutant, A156S. Both InterMune compounds also showed strong potency against the BILN-2061 resistant protease mutant, D168V. The study also demonstrated uncompromised in vitro potency of the InterMune protease inhibitors against an HCV replicon insensitive to interferon alpha-2a. These results suggest that a virus imposed block to the antiviral actions of interferon may be alleviated by these HCV protease inhibitors.
About InterMune
InterMune is a biopharmaceutical company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a broad and deep late-stage product portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus infections, particularly nonresponders, or those patients who do not respond to first-line therapy. The pulmonology portfolio includes Actimmune(R) and pirfenidone. Actimmune(R) is being evaluated in the INSPIRE Trial, a Phase III study in patients with IPF. Pirfenidone is also being developed for the treatment of IPF. In addition to three-times-a-week Infergen(R), a currently marketed product indicated for the treatment of chronic HCV infections, the hepatology portfolio includes the DIRECT Trial, a Phase III study of daily Infergen(R) plus ribavirin in nonresponders. Additionally, InterMune is developing a pre-clinical stage small molecule program targeted at the HCV protease. For additional information about InterMune and its development pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. 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 quarterly report on Form 10-Q filed with the SEC on November 7, 2005 (the “Form 10-Q”) and other periodic reports filed with the SEC, including the following: (i) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (ii) risks related to achieving positive clinical trial results; (iii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; and (iv) risks related to significant regulatory barriers to entry. 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-Q and InterMune’s other periodic reports filed with the SEC.
InterMune, Inc.
CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com; or media, Pam Lord of Atkins + Associates,+1-858-527-3494, or plord@irpr.com, for InterMune, Inc.
Web site: http://www.intermune.com/
