Pirfenidone was developed in Japan for the treatment of idiopathic pulmonary fibrosis (IPF) by Shionogi, which has rights to pirfenidone in Japan, Taiwan and South Korea.
InterMune has also provided a progress report on its Phase III Capacity program of pirfenidone in IPF. Capacity consists of two multinational, randomized, double-blind, placebo-controlled Phase III studies with a total enrollment of 779 IPF patients at 110 centers in the US, Europe and Australia. The primary endpoint in Capacity is change in forced vital capacity from baseline to week 72.
InterMune reported that 97% of transplant-free, surviving patients had completed their week 72 visit, the study visit at which the primary endpoint is assessed. Pirfenidone has been granted orphan drug and fast track designation in the US and orphan drug designation in Europe for the treatment of IPF.
Dan Welch, chairman, CEO and president of InterMune, said: “As we approach the last patient visits in our two Capacity studies, we are extremely pleased with the quality of the study conduct and to have exceeded our aggressive goal for having at least 95% of transplant-free, surviving patients reporting for their week 72 visit. We look forward to reporting top-line results of Capacity in January or in February of 2009.”