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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

ally significant and clinically meaningful effect on both the primary endpoint of change in percent predicted FVC and secondary endpoints of progression-free survival and categorical change in percent predicted FVC. While CAPACITY 1 did not achieve statistical significance on the primary endpoint, the results were generally consistent with and supportive of CAPACITY 2. Further, the treatment effect observed in the CAPACITY studies was generally consistent with that observed in the Phase 3 study of pirfenidone in IPF patients conducted by Shionogi & Co. Ltd. in Japan."

Dr. Roland du Bois, Professor of Medicine at National Jewish Health, Denver, Colo., and CAPACITY co-chair also commented on the CAPACITY results. "When taken in the context of the urgent unmet medical need for new medicines to treat IPF patients, the collective efficacy and safety data from the two CAPACITY studies, corroborated by a similar study in Japan, make a case for the use of pirfenidone in this disease setting."

Primary Efficacy Endpoint Results

The primary endpoint of both CAPACITY studies was change in percent predicted Forced Vital Capacity (FVC) after 72 weeks of treatment, evaluated with a nonparametric rank ANCOVA. In the CAPACITY 2 study, the primary endpoint was met (p=0.001). In CAPACITY 1, the primary endpoint was not met (p=0.501). An exploratory analysis of pooled primary endpoint data from both studies using the pre-specified primary endpoint test statistic from a nonparametric rank ANCOVA resulted in a P value of 0.005.

A pre-specified repeated measures analysis of the primary endpoint was used to obtain a least squares mean estimate (LS mean) of the magnitude of the treatment effect. The LS mean change in percent predicted FVC at Week 72 was -6.5% and -9.6% in the pirfenidone and placebo groups, respectively, in CAPACITY 2, and -6.5% and -7.2%, respectively, in CAPACITY 1. This represents
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