Esbriet meets endpoints in Pulmonary Fibrosis study - InterMune

InterMune has announced that top-line data from ASCEND, a Phase III trial evaluating Esbriet (pirfenidone) in patients with Idiopathic Pulmonary Fibrosis (IPF) has met primary and secondary endpoints. The data demonstrates that pirfenidone significantly reduced IPF disease progression as measured by change in percent predicted forced vital capacity (FVC) from Baseline to Week 52. Additionally, significant treatment effects were demonstrated on both of the key secondary endpoints of six-minute walk test distance (6MWD) change and progression-free survival (PFS). 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.

Additionally, at Week 52 the data demonstrated that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group. In ASCEND, pirfenidone also reduced by 27.5% the proportion of patients who experienced a decline in 6MWD of 50 meters or greater. It also reduced the risk of death or disease progression by 43% compared to placebo. Finally pirfenidone showed a favorable safety profile and was generally well tolerated.