BRISBANE, Calif., May 16 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that patient enrollment has been completed in CAPACITY, the company's Phase 3 clinical program to evaluate pirfenidone as a treatment for patients with idiopathic pulmonary fibrosis (IPF).
"We are very pleased to have completed enrollment of the CAPACITY program seven months ahead of the original schedule, and with 194 more patients than originally planned," said Steve Porter, M.D., Ph.D. and Chief Medical Officer of InterMune. "The rapid pace of enrollment clearly reflects strong interest by investigators and patients. We look forward to sharing top-line results from CAPACITY, which are now expected to be available around the end of 2008."
The CAPACITY program includes two multinational, randomized, double-blind, placebo controlled Phase 3 trials, named CAPACITY 1 and CAPACITY 2, designed to evaluate the safety and efficacy of pirfenidone in IPF patients with mild to moderate impairment in lung function. The primary endpoint of both trials is lung function, as measured by change in forced vital capacity (FVC). The two trials have enrolled a total of 779 patients at 110 centers in North America and Europe. Enrollment was completed in less than 13 months following randomization of the first patient into the program in late April 2006.
InterMune noted that the design of the Phase 3 CAPACITY program reflects the following data and information:
-- In March of 2007, Shionogi and Co., Ltd. reported that in its Phase 3 trial of pirfenidone in IPF in Japan, the primary efficacy endpoint, change in vital capacity (VC), was met with statistical significance in both the high-dose and low-dose treatment groups compared to placebo, representing 44% and 50% relative reductions in VC decline, respectively, over 52 weeks; -- InterMune's CAPACITY program has greater than 95% power to detect a 50% reduction in the rate of FVC progression and greater than 85% power to detect a 40% reduction after 72 weeks of treatment, compared to placebo; -- An understanding of the natural history of the disease based on observed changes in forced vital capacity (FVC) and other important measures of lung function over time in the placebo group of the recently un-blinded INSPIRE trial of Actimmune(R) in IPF informed the assumptions of FVC decline of the placebo group in CAPACITY; -- Pirfenidone appears to have a positive effect on lung function, measured by VC or FVC, as suggested in several Phase 2 studies as well as the Shionogi Phase 3 study; and -- FVC as the primary endpoint of CAPACITY is supported by the FDA and the EMEA.
"Study conduct in CAPACITY has been excellent, as we have experienced a very low patient drop-out rate to date with over 750 patients enrolled and having conducted the program for more than one year," Dr. Porter added. "A well-designed and well-powered study, combined with excellent study conduct, provide confidence that we are well positioned to determine the extent to which pirfenidone can fill the significant unmet medical need for a new medicine to help patients suffering from IPF."
A Significant Unmet Medical Need
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, with approximately 30,000 new cases developing each year. There are no drugs approved by the FDA or EMEA for the treatment of IPF. By comparison, each year there are approximately 5,000 to 6,000 new diagnoses of pulmonary arterial hypertension, approximately 10,000 patients diagnosed with multiple sclerosis and about 26,000 patients diagnosed with ovarian cancer. Each of these supports pharmaceutical markets valued at over one billion dollars in annual revenue.
About IPF
IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%. Patients diagnosed with IPF are usually between the ages of 40 and 70, and the disease tends to affect men more than women.
About Pirfenidone
Prior in vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients suggest that pirfenidone may positively affect lung function and disease progression in patients with IPF. In these clinical studies, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. Both the U.S. Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) have granted pirfenidone orphan drug designation for the treatment of IPF. InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases. Pirfenidone is un-partnered at this time.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a portfolio of compounds 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 in Phase 1a, 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.
Forward-Looking Statements
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 future financial results and product development. 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 30, 2007 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (ii) risks related to achieving positive clinical trial results; (iii) risks related to timely patient enrollment and retention in clinical trials; (iv) the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone; and (v) the results as reported by Shionogi concerning their Phase 3 trial may differ from those published or presented in a peer-reviewed forum. 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 www.intermune.com.
InterMune, Inc.CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228, jgoff@intermune.com
Web site: http://www.intermune.com//
