InterMune begins phase 3 program evaluating pirfenidone in pulmonary fibrosis patients

By Lisa Kerner

Erie, Pa., April 27 - InterMune, Inc. began patient enrollment in its phase 3 clinical program, known as Capacity, to evaluate pirfenidone, a small molecule p38-gamma inhibitor, as a treatment for patients with idiopathic pulmonary fibrosis, a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States.

Capacity includes two multinational, randomized, double-blind, placebo controlled phase 3 trials (Capacity 1 and Capacity 2) designed to evaluate the safety and efficacy of pirfenidone in patients with mild to moderate impairment in lung function.

For both trials, the primary endpoint is lung function as measured by change in forced vital capacity.

A total of 580 patients will be enrolled in the trials at more than 120 centers in North America and Europe, according to a company news release.

"The level of clinical investigator interest in the Capacity program is very high so we believe enrollment of this phase 3 program will advance relatively quickly and conclude toward the end of 2007," president and chief executive officer Dan Welch stated in the release.

"Top-line data from Capacity are expected in early 2009."

Patients in Capacity 1, randomized 1:1, will receive either three 267 mg capsules of pirfenidone three times per day or a placebo. In Capacity 2, patients will be randomized 2:1:2 to receive either three 267 mg capsules of pirfenidone, three 133 mg capsules of pirfenidone or placebo, three times a day.

All study participants will receive treatment for 60 weeks, with four weeks of follow up.

InterMune is a Brisbane, Calif., biotechnology company developing therapies in pulmonology and hepatology.

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