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Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)
Date:5/19/2009

ll six assessment periods, including Week 72, in CAPACITY 2, and at all four of the assessment periods through Week 48 in CAPACITY 1, but not at Week 72. An analysis of pooled data from the two CAPACITY studies showed that placebo-treated patients experienced a mean of 76 mL more decline in FVC than patients who received pirfenidone at Week 72. At Week 48, patients who received pirfenidone experienced a mean of 169 mL less FVC decline compared to placebo in CAPACITY 2 (p=0.002) and a mean of 54 mL less FVC decline in CAPACITY 1 (p=0.006). This pattern of change is consistent with that observed at Week 52 in the Phase 3 study of pirfenidone conducted by Shionogi.

Categorical Analysis of Change in Six-Minute Walk Test (6MWT) Distance

Post-hoc analyses of data from the 826-patient INSPIRE trial suggested that patients experiencing a 50-meter decrement in distance walked during the 6MWT at six months had an approximately 2.5-fold increased risk in mortality. Using this threshold, 33% and 47% of pirfenidone and placebo patients, respectively, in CAPACITY 1 (p=0.013), and 37% and 47% of pirfenidone and placebo patients, respectively, in CAPACITY 2 (p=0.032) experienced this magnitude of change. In a pooled analysis, 35% and 47% of pirfenidone and placebo patients, respectively, experienced a change that exceeded this threshold (p=0.001).

Safety and Tolerability Results

Safety data presented for both studies showed that pirfenidone given as 2403 mg per day was safe and generally well tolerated. In CAPACITY 2, 83% and 90% of surviving, lung transplant-free patients completed therapy per protocol in the pirfenidone and placebo groups, respectively, and 82% and 90%, respectively, of patients did so in CAPACITY 1. The percentage of patients discontinuing treatment due to an adverse event across both studies combined was 15% and 9% in the pirfenidone and placebo groups, respectively.

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SOURCE InterMune, Inc.
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