Enrollment commences in InterMune's Esbriet Phase 3 study for IPF

InterMune (NASDAQ: ITMN) today announced that patient enrollment has begun in ASCEND, a new Phase 3 study of pirfenidone for patients who suffer from idiopathic pulmonary fibrosis (IPF).  ASCEND is a multinational, randomized, double-blind, placebo controlled Phase 3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone) in IPF patients with mild to moderate impairment in lung function.  The primary endpoint is lung function, as measured by change in forced vital capacity (FVC) from baseline to Week 52.  The trial will enroll a total of approximately 500 patients who will be randomly assigned 1 to 1 to receive oral pirfenidone (2403 mg/day) or placebo.  Patients will be enrolled at centers in the United States, Mexico, South America, Australia and New Zealand.  

Steve Porter, M.D., Ph.D., Chief Medical Officer of InterMune, said, "We are very pleased to report enrollment of the first patient in ASCEND.  This study represents our continued commitment to making Esbriet available for the more than 100,000 IPF patients in the United States who are afflicted with IPF but currently have no FDA-approved therapies available to them."  

ASCEND Phase 3 Trial

InterMune's new Phase 3 study of pirfenidone is named ASCEND (Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF).  ASCEND will add to pirfenidone's body of clinical evidence and support a future submission for FDA approval.

InterMune expects the trial to be fully enrolled by the first half of 2012, and that results from the study will be available in mid-2013.  InterMune anticipates a New Drug Application (NDA) resubmission for pirfenidone in the second half of 2013 and an FDA action in the first half of 2014.  

Relative to InterMune's previous studies of pirfenidone in IPF, the entry criteria for ASCEND have been refined to enrich the study population for patients who are more likely to experience decline in lung function and disease progression during the study.  InterMune believes that enrolling patients whose disease is more likely to progress will provide greater opportunity to demonstrate a treatment effect in a one-year study.  While the entry criteria have been refined, the study is conservatively powered based on the intent-to-treat analyses from the previous CAPACITY Phase 3 program.  

Patient eligibility criteria for ASCEND include the following:

• Centrally confirmed diagnosis by High Resolution Computed Tomography (HRCT) (+/- surgical lung biopsy)
• HRCT extent of fibrosis greater than emphysema
• %FVC  50% - 90%
• %DLco  30% - 90%
• FEV1/FVC ratio greater than 0.80
• Time since IPF diagnosis greater than six months and less than four years

The primary endpoint in the ASCEND study is change in percent predicted FVC, with the primary outcome analysis a Rank ANCOVA at Week 52.  The magnitude of effect will be presented on a categorical basis as the proportion of patients with decrements of less than 0% or greater than 10% at pre-specified study time points.

Key secondary endpoints include change in six-minute walk test (6MWT) distance and progression-free survival, which will be based on the earliest of time to death, FVC decrement of 10% or greater, or decrement in 6MWT distance of 50 meters or more.

Other secondary endpoints include all-cause mortality, evaluated both independently as well as pooled with the previous CAPACITY data, and on-treatmet IPF-related deaths, which also will be evaluated independently and pooled with the CAPACITY data, and dyspnea.