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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

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

To better understand the primary efficacy outcome, InterMune conducted an exploratory analysis that interrogated the time course of the pirfenidone treatment effect. The results of an exploratory repeated measures analysis of ranked change from baseline, assessing treatment effect over the full duration of the study showed that pirfenidone reduced the decline in FVC in both studies (CAPACITY 2, p=0.004 and CAPACITY 1, p=0.001).

Secondary Efficacy Endpoint Results

In CAPACITY 2, treatment with pirfenidone was associated with a statistically significant effect on the pre-specified secondary endpoints of PFS (p=0.023) and Categorical Change in FVC (p=0.001) when compared to placebo. A PFS event was defined in the study protocol as the time to death, a 10% decrease in FVC or a 15% decrease in DLco. In CAPACITY 1, pirfenidone treatment was associated with a treatment effect in the pre-specified secondary endpoint of Six-Minute Walk Test distance (p=0.001) when compared to placebo. There were no other statistically significant findings on any of the other pre-specified secondary endpoints in either study and pirfenidone treatment was not associated with a worse outcome on any endpoints.

Analyses of pooled data for the pre-specified secondary endpoints of both CAPACITY studies showed a treatment effect favoring pirfenidone on three: PFS (p=0.029); Categorical FVC Change (p=0.003) and Six-Minute Walk Test distance (p=0.001). Although pooled analyses of secondary endpoints were pre-specified in the study protocols, these analyses are nonetheless considered exploratory because the primary endpoint of both studies was not met.

The pooled analysis of Categorical FVC Change showed that 30% fewer patients experienced a 10% or greater decrease in FVC at week 72 in the pirfenidone group than in the placebo group. This magnitu
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SOURCE InterMune, Inc.
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