LOS ANGELES, May 23 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today the presentation of research describing the preclinical characterization of ITMN-191 (previously referred to as ITMN B), its orally available hepatitis C virus (HCV) NS3/4A protease inhibitor. The preclinical findings were presented at the Digestive Disease Week (DDW) meeting in Los Angeles. InterMune expects to submit a European Clinical Trial Authorization for ITMN-191 in the third quarter of 2006.
In an oral presentation and Poster of Distinction at DDW, Scott Seiwert, Ph.D., Vice President of Discovery Research at InterMune, described the characterization of ITMN-191 activity against various HCV N3/4A protease variants. ITMN-191 retains activity against variants that exhibit reduced sensitivity to other experimental HCV protease inhibitors in development. A single variant was identified that shows diminished potency to ITMN-191. However, this variant is distinct from variants that have reduced sensitivity to other HCV protease inhibitors. This demonstrates a favorable cross-resistance profile of ITMN-191 with other HCV protease inhibitors currently in development.
Also at DDW, the chemical structure of ITMN-191 was revealed for the first time, demonstrating the distinguishing characteristics between ITMN-191 and other experimental HCV protease inhibitors. InterMune and its collaborators utilized structure-based drug design to optimize drug-target binding interactions. The researchers credit the tight binding between ITMN-191 and the HCV protease for the experimentally observed high potency of ITMN-191 and activity against variants of the protease that are resistant to other HCV protease inhibitors.
Structural optimization also enabled InterMune to improve compound exposure to the liver in animal models. Given that viral replication of HCV is reported to occur primarily in hepatocytes, achieving high drug concentrations in liver is believed to be critical to the clinical success of target therapies against HCV. Further in vivo studies reveal favorable high liver exposure of ITMN-191 across multiple species at potentially clinically relevant dosing concentrations. The results continue to support exploration of twice-daily, oral dosing in treatment of chronic HCV.
"Our research team's detailed characterization of ITMN-191 provides important insight regarding how our compound is distinct from other experimental HCV protease inhibitors in development and reinforces our confidence that ITMN-191 has the potential to be a superior drug candidate with favorable cross resistance and potency profiles," said Dan Welch, President and CEO of InterMune.
About HCV and HCV Protease Inhibitors
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches. HCV protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4 protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.
About InterMune
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 two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF: the INSPIRE trial is evaluating Actimmune(R) (interferon gamma-1b) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the lead HCV protease inhibitor compound, ITMN-191, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D 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 annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and updates included in the most recent Form 10-Q filed with the SEC on May 9, 2006 (the "Form 10-Q"), and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. 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.
InterMuneCONTACT: investors, Investor Relations Dept of InterMune, Inc.,+1-415-466-2242, or ir@intermune.com; or media, Pam Lord of Porter NovelliLife Sciences, +1-858-527-3494, or plord@pnlifesciences.com
Web site: http://www.intermune.com//
