Phase 3 Studies of Pirfenidone for Idiopathic Pulmonary Fibrosis

InterMune announced positive data from its CAPACITY Program studying pirfenidone for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).  The CAPACITY Program is comprised of two Phase 3, multinational, double-blind, placebo-controlled studies (Study 004 and 006) conducted simultaneously for 72 weeks. The studies enrolled a total of 779 IPF patients 40–80 years old.

Study 004 data showed that pirfenidone reduced the decline in forced vital capacity (FVC) in IPF patients (P=0.001).  The mean FVC change at Week 72 was -8% in the pirfenidone group compared with 12.4% in the placebo group.  In addition, treatment with Pirfenidone reduced the proportion of patients with FVC decline of ≥10% compared to placebo (35 of 174 patients vs 60 of 174 patients). Data from Study 006 showed that the difference between groups in FVC change at Week 72 was not significant; however, a consistent and statistically significant pirfenidone treatment effect was evident through one year of treatment.  The repeated-measures analysis of percent predicted FVC change over all study timepoints showed a favorable pirfenidone treatment effect in both studies.

Pirfenidone is an orally active antifibrotic and anti-inflammatory drug that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis.  It also inhibits the synthesis of TNF-alpha, a cytokine that plays an active role in inflammation.  

For more information call (415) 466-2200 or visit www.intermune.com/Pirfenidone.