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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

de of decline is considered clinically meaningful as a 10% decline in percent predicted FVC has been shown in multiple studies to be an independent predictor of mortality in patients with IPF. In addition, 40% more patients in the pirfenidone group did not experience a decline in percent predicted FVC at week 72 versus baseline compared to those who received placebo.

While the studies were not powered to demonstrate an effect on overall survival, a pre-specified exploratory endpoint, the pooled hazard ratio (pirfenidone: placebo) was 0.77 (p=0.326).

ADDITIONAL EXPLORATORY EFFICACY RESULTS REPORTED AT ATS

The ATS presentation highlighted new efficacy data from CAPACITY pertaining to dose-effect relationships, mean change in FVC volume and Six-Minute Walk Test distance.

Dose Relationships

In the CAPACITY 2 study, patients were randomized 2:2:1 to receive a total daily dose of 2403 mg pirfenidone, or placebo, or a total daily dose of 1197 mg pirfenidone, respectively. The lower dose of pirfenidone in CAPACITY 2 was included to explore dose-effect relationships in a descriptive fashion. Dr. Noble reported at the ATS meeting data on the low-dose pirfenidone group for the efficacy outcome measures of change in percent predicted FVC, PFS and DLco. On each of these outcome measures, the effect of 1197 mg was intermediate as compared to placebo and 2403 mg pirfenidone, indicative of a consistent dose-effect relationship. Similarly, a dose-response relationship was observed on a number of safety outcome measures.

Change in FVC Volume

Pre-specified analyses of change in FVC were based on percent predicted FVC and not volume. Given the clinical interest in FVC volume, data on change in this parameter were reported at ATS. Similar to the results of the primary endpoint analysis, evidence of a pirfenidone treatment effect on this endpoint was observed at a
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SOURCE InterMune, Inc.
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