InterMune reports mixed results from Phase III trials of lung drug

According to the company, the primary endpoint of change in percent predicted forced vital capacity (FVC) at week 72 was met with statistical significance in Capacity 2 (p=0.001), along with the secondary endpoints of categorical change in FVC and progression-free survival (PFS). The primary endpoint was not met in Capacity 1 (p=0.501), but supportive evidence of a pirfenidone treatment effect was observed on a number of measures.

Pirfenidone was safe and generally well tolerated in both Capacity studies. The company is preparing a new drug application (NDA) for submission to the FDA, to be followed by a marketing authorization application (MAA) submission to the EMEA.

The Capacity program consisted of two multinational, randomized, double-blind, placebo-controlled Phase III trials, named Capacity 1 and Capacity 2, designed to evaluate the safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis (IPF) patients with mild to moderate impairment in lung function. Both trials enrolled patients in North America, Europe and Australia with roughly 75% of the total 779 patients enrolled in North America.

Dan Welch, chairman, CEO and president of InterMune, said: We are very pleased by the overall efficacy and safety of pirfenidone in the treatment of IPF provided by the two Capacity studies.

We believe that the efficacy data from both of the Capacity studies as well as Shionogi’s Phase III study, the compelling safety and tolerability profile observed in Capacity, together with the urgent unmet medical need for new medicines to treat IPF strongly support our decision to move forward with our NDA and an MAA submissions for pirfenidone as soon as possible.