A double-blind, randomized, placebo-controlled Phase II trial evaluating pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF) has suggested favourable effects of pirfenidone on acute exacerbations and other efficacy parameters, prompting the decision to stop the trial, InterMune, Inc. announced here.

This 107- patient study with a planned 12-month treatment period was conducted in Japan by Shionogi & Co., LTD and was terminated after only nine months based on the recommendation of the Data Safety Monitoring Board following an interim analysis.

"This study suggests that treatment with pirfenidone may prevent acute exacerbation of IPF and reduce the rate of decline in vital capacity," Dan Welch, InterMune's president and CEO said adding, "We are encouraged by these promising results and are moving forward with our discussions with the US Food and Drug Administration and the European Medicines Agency regarding the design of a Phase III development program for pirfenidone in IPF, which we expect to initiate in the first half of 2006."

InterMune acquired an exclusive license relating to the manufacture, use and sale of pirfenidone for antifibrotic use worldwide, excluding Japan, Korea, and Taiwan, where rights are held by Shionogi & Co., LTD.

The American Journal of Respiratory and Critical Care Medicine (AJRCCM) has published results from the study.