InterMune announced results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta and TNF-alpha.
ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF) is a multinational, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of pirfenidone in patients with IPF. Patients (N=555) were randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or placebo. More than 95% of eligible patients who completed the ASCEND study decided to enter the open-label RECAP extension study, in which all patients receive pirfenidone. RECAP also includes patients rolled over from the company’s prior CAPACITY studies, which were completed in late 2008 and enrolled 779 patients in two Phase 3 studies.
The treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a 10% decline in FVC, or death. In ASCEND, pirfenidone significantly reduced decline in lung function as measured by change in percent predicted forced vital capacity (FVC) from Baseline to Week 52 (rank ANCOVA P<0.000001).
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 this meaningful decline in FVC or death. Additionally, at Week 52, the results demonstrated that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group, representing a 132.5% increase in the proportion of patients who experienced no decline in FVC between Baseline and Week 52.
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