InterMune Inc. reported that results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) were presented at the International Conference of the American Thoracic Society (ATS) in San Diego, and published on-line in the New England Journal of Medicine. Dr. Talmadge King, professor and chair, Department of Medicine, University of California, San Francisco and Co-chair of the ASCEND protocol steering committee, presented the ASCEND results.
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). Additionally, significant treatment effects were demonstrated on both of the key secondary endpoints of change in six-minute walk distance (6MWD) (p=0.0360) and progression-free survival (PFS) (p=0.0001). The secondary endpoint of dyspnea (shortness of breath) was not met. In ASCEND, treatment with pirfenidone was associated with fewer deaths although the study was not powered for and did not reach statistical significance on mortality. A pre-specified analysis of the pooled population from ASCEND and the two Phase 3 CAPACITY studies showed that the risk of all-cause mortality was reduced by 48% at Week 52 in the pirfenidone group compared to the placebo group (Hazard Ratio [HR] 0.52, log rank p=0.0107). In ASCEND, treatment with pirfenidone showed a favorable safety profile and was generally well tolerated.
IPF is a chronic, progressive, and irreversible lung disease characterized by scarring in the lungs, which hinders a person’s ability to breathe. The median survival time from diagnosis is two to five years, which makes IPF more rapidly lethal than many malignancies, including breast, ovarian and colorectal cancers.
King said, “Pirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival in patients with idiopathic pulmonary fibrosis. Treatment was associated with an acceptable side effect profile and fewer deaths.”
Dan Welch, chairman, CEO and president of InterMune, said, “The presentation of the ASCEND results at ATS and publication in the New England Journal of Medicine represents an important milestone in the decade of clinical research we have conducted on pirfenidone. The study results provide strong evidence of pirfenidone’s robust treatment effects and augment its already well-established safety and tolerability profile. We currently intend to resubmit the pirfenidone New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the coming weeks.”
Date: May 18, 2014