Steve Porter, M.D., Ph.D., Chief Medical Officer of InterMune, said, "While the primary endpoint was met in just one of two CAPACITY studies, there are significant consistencies across the two studies in the overall treatment effect of pirfenidone on lung function and exercise tolerance. In addition, the Study Week 48 results from both CAPACITY studies are consistent with those of the primary efficacy endpoint, change in Vital Capacity at Week 52, in the Shionogi Phase 3 study. Considering the favorable safety profile of pirfenidone and the lack of any approved treatment options for IPF patients, we believe the collective data suggest pirfenidone may play a meaningful role in the management of patients suffering from this devastating disease."
Dr. Porter continued, "We are greatly indebted to the many patients, health care providers and study personnel who dedicated themselves to the successful conduct of the CAPACITY program and enabled us to deliver high quality data."
About CAPACITY and RECAP
The CAPACITY program consisted of 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 was change in percent predicted Forced Vital Capacity (FVC) after 72 weeks of treatment evaluated with a nonparametric rank ANCOVA analysis. Both trials enrolled patients in North America, Europe and Australia with roughly 75% of the total 779 patients enrolled in North America.
CAPACITY 1 enrolled a total of 344 patients. Pati
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