Positive Phase III data for Esbriet in Pulmonary Fibrosis-InterMune

InterMune has presented the results of pooled analyses of data from three Phase III trials (ASCEND [Study 016] and CAPACITY [Studies 004 and 006]) that provide evidence of a durable Esbriet (pirfenidone) treatment benefit on multiple measures of disease status in patients with idiopathic Pulmonary Fibrosis (IPF) who continue through up to 72 weeks of treatment. Analyses at the study primary endpoint, in which patients were treated for 52 weeks in ASCEND and 72 weeks in CAPACITY, show a 52% reduction in the risk of a ?10% decline in percent predicted forced vital capacity (FVC) or death. The analyses also show a 34% reduction in the risk of a ?50m decline in 6-minute walk distance (6MWD) or death, and the progression-free survival analysis showed the risk of disease progression was reduced by 38% survival in the pirfenidone group compared with placebo.

Additionally, the risk of all-cause mortality was reduced by 37% and the risk of treatment emergent IPF-related mortality was reduced by 60% in the pirfenidone group compared with placebo. The risk of a ?20 point increase in UCSD SOBQ score or death was decreased by 25% at study endpoint. Safety outcomes were consistent with prior observations. Professor Paul W. Noble, M.D. from the Cedars-Sinai Medical Center, Los Angeles, presented the data at the European Respiratory Society Annual Congress 2014.

A separate study examined the long-term safety of pirfenidone in patients with IPF enrolled in the RECAP study, an extension study evaluating continued therapy in patients who completed one of the Phase III trials. Interim analysis showed that long-term treatment with pirfenidone has a favourable safety profile and is generally well tolerated for up to 4.9 years.