InterMune, Inc. 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.

"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."

Source: InterMune, Inc. Press Release 5/16/07