Pirfenidone Shows Positive Phase III Results

16 May 2011 (Last Updated May 16th, 2011 18:30)

InterMune has published positive results from two Phase III trials of pirfenidone on lung function, six-minute walking distance test and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis in The Lancet. Idiopathic pulmonary fibrosis is a

InterMune has published positive results from two Phase III trials of pirfenidone on lung function, six-minute walking distance test and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis in The Lancet.

Idiopathic pulmonary fibrosis is a rare and fatal lung disease characterised by inflammation and scarring in the lungs.

The two multinational, double-blind, placebo-controlled studies, numbered 004 and Study 006, included 779 patients with idiopathic pulmonary fibrosis and showed a favourable pirfenidone treatment with a decline in FVC, an important measure of lung function.

In the pooled analysis, the drug molecule showed a decline in six-minute walking distance test and also a prolonged progression-free survival by 26% compared with placebo.

Paul Noble, chief of Duke University School of Medicine’s Division of Pulmonary, Allergy, and Critical Care Medicine, said that though only Study 004 achieved the primary end point, the totality of the data from Study 004 and 006 provide evidence of a clinically meaningful treatment effect of pirfenidone, with a safety profile in idiopathic pulmonary fibrosis patients.

The adverse reactions observed with pirfenidone were nausea, rash, fatigue, diarrhoea, dyspepsia and photosensitivity reaction.

Pirfenidone is an orally active, antifibrotic and anti-inflammatory drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis.