Pirfenidone, a novel antifibrotic and anti-inflammatory drug, 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.
In Study 004 pirfenidone showed reduction in the decline of Forced Vital Capacity (FVC) in IPF patients.
In addition, treatment with pirfenidone reduced the proportion of patients with FVC decline of 10% or more compared to placebo (35 of 174 patients vs 60 of 174 patients).
In Study 006, the difference between groups in FVC change at week 72 was not significant, however, a consistent pirfenidone treatment was evident through one year of treatment.
Duke University School of Medicine Allergy and Critical Care Medicine Division of Pulmonary chief Paul Noble said although the results of Study 004 and 006 were not identical and only Study 004 achieved the primary end point, the totality of the data provide compelling evidence of a clinically meaningful treatment effect of pirfenidone, together with a favorable safety profile in patients with IPF.