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

first 48 weeks of treatment. For example, in CAPACITY 2 and CAPACITY 1 the Week 48 rank ANCOVA p values were 0.001 and 0.005; the relative reductions in LS means from the repeated measures analysis were 46% and 29%, respectively. The difference between the CAPACITY 2 and CAPACITY 1 primary endpoint results at Week 72 may have been due to a modest attenuation in the rate of FVC decline in the placebo group subsequent to Week 48 in CAPACITY 1.

Secondary Endpoint Results

In CAPACITY 2, pirfenidone treatment 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 DL(CO). In CAPACITY 1, pirfenidone treatment was associated with a statistically significant 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.

Although pooled analyses of secondary endpoints were pre-specified in the study protocol, these analyses are nonetheless considered exploratory because the primary endpoint of both studies was not met. 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 = 0.004). While the studies were not powered to demonstrate an effect on overall survival, the pooled hazard ratio (pirfenidone: placebo) was 0.78 (p= 0.326).

Safety and Tolerability Results

Safety data from both studies show that pirfenidone wa
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