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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

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There was no difference between pirfenidone and placebo in the percentage of patients who experienced a serious adverse event (SAE). An SAE was reported by 35% and 33% of pirfenidone and placebo groups, respectively, in CAPACITY 2 and by 31% and 30%, respectively, in CAPACITY 1. While there was a slightly higher incidence of Grade 3 adverse events in the pirfenidone groups in both studies, there was no difference in overall Grade 4 adverse events between pirfenidone and placebo.

The pattern of adverse events was in general comparable to that observed in previous clinical studies of pirfenidone. The most common adverse events in the pirfenidone group as compared to placebo were nausea (35% vs. 18% in CAPACITY 2 and 38% vs. 16% in CAPACITY 1), rash (31% vs. 10% and 34% vs. 13%), fatigue (28% vs. 21% and 33% vs. 20%), diarrhea (25% vs. 17% and 33% vs. 21%), dyspepsia (17% vs. 9% and 21% vs. 6%), and dizziness (19% vs. 10% and 18% vs. 10%). Rash was generally mild to moderate in both studies; only 2 patients (1 in each CAPACITY study) receiving pirfenidone experienced a severe rash.

ADDITIONAL SAFETY RESULTS REPORTED

The ATS presentation reported new safety data from the CAPACITY studies pertaining to the incidence and cause of deaths, treatment discontinuations due to adverse events and laboratory tests.

Incidence and Cause of Deaths

Analysis of the incidence and cause of death revealed that fewer patients in the pirfenidone 2403 mg group compared with placebo died during the treatment period, defined as the time from the first dose until 28 days after the last dose of study treatment. In CAPACITY 1, 5.3% of patients in the pirfenidone group died during the treatment period, compared with 8.7% in the placebo group. In CAPACITY 2, 5.7% of patients in the pirfenidone group died during the treatment period, compared with 8.0% in the placebo group.

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SOURCE InterMune, Inc.
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