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InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
Date:2/3/2009

dy, the compelling safety and tolerability profile observed in CAPACITY, together with the urgent unmet medical need for new medicines to treat IPF strongly support our decision to move forward with our NDA and an MAA submissions for pirfenidone as soon as possible. IPF is a disease that is more lethal than almost every form of cancer, affects almost 250,000 Americans and Europeans combined, and for which there are no medicines approved for their treatment."

Primary 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 a relative reduction of 32% in CAPACITY 2 and 10% in CAPACITY 1.

To better understand the primary efficacy outcome, InterMune conducted a series of exploratory analyses interrogating the time course of treatment effect. An exploratory repeated measures analysis of ranked change from baseline, assessing treatment effect over the full duration of the study suggested pirfenidone reduced the decline in FVC in both studies (CAPACITY 2 p = 0.004 and CAPACITY 1 p = 0.001). In both studies, the magnitude of treatment effect generally was most pronounced in the
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SOURCE InterMune
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