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InterMune Plans Pirfenidone Pulmonary Fibrosis Phase III Study In 2006

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

InterMune's pivotal trials of pirfenidone will be the first Phase III studies of an idiopathic pulmonary fibrosis drug to use the primary endpoint of lung function as measured by change in forced vital capacity

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InterMune IPF drug enters Phase III

InterMune commences enrollment of Phase III CAPACITY program evaluating pirfenidone for treatment of idiopathic pulmonary fibrosis (IPF), the firm says April 27. The dual-trial program "will advance relatively quickly and conclude toward the end of 2007," CEO Dan Welch states. Top-line data are expected in early 2009. InterMune finalized the studies' designs with FDA last fall; the company has pointed to CAPACITY as the first IPF program to utilize lung function as the primary endpoint (1Pharmaceutical Approvals Monthly November 2005, p. 6). Pirfenidone is a small molecule p38-gamma inhibitor. Other firms developing IPF treatments include Actelion, CoTherix and Novartis...

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