InterMune Reports Phase 3 ASCEND Trial Results Of Pirfenidone - Quick Facts

(RTTNews) - InterMune Inc. (ITMN) announced that top-line data from ASCEND, a Phase 3 trial assessing pirfenidone in patients with idiopathic pulmonary fibrosis or IPF, showed that pirfenidone significantly reduced IPF disease progression as measured by change in percent predicted forced vital capacity or FVC from Baseline to Week 52. Further, significant treatment effects were demonstrated on both of the key secondary endpoints of six-minute walk test distance change and progression-free survival.

Chairman, Chief Executive and President of InterMune stated: "Based on the strength of the ASCEND results, InterMune is preparing a resubmission of our New Drug Application for pirfenidone to the U.S. Food and Drug Administration (FDA), which we expect to submit by early third quarter of this year. We would like to thank our collaborators, patients and their families for their participation in ASCEND and their contributions to IPF research."

The magnitude of the treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a clinically meaningful change in FVC, or death. A 10% decline in FVC in an individual IPF patient is considered clinically meaningful and strongly predicts mortality.

At Week 52, 16.5% of patients in the pirfenidone group experienced an FVC decline of 10% or more or death, compared with 31.8% in the placebo group, representing a 47.9% reduction in the proportion of patients who experienced a meaningful change in FVC or death.

The ASCEND protocol pre-specified 6MWD and PFS as the two key secondary endpoints.