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

ents were randomized 1:1 to receive a total daily dose of 2403 mg pirfenidone, or placebo. CAPACITY 2 enrolled a total of 435 patients, and 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, administered in three divided doses. The lower dose of pirfenidone in CAPACITY 2 provided safety and tolerability data. The pre-specified statistical analysis plan did not call for this low-dose group to be used in any analyses of efficacy. The pooled analyses of the primary and secondary efficacy outcome measures were based on a combined analysis of the 2403 mg group compared with the placebo group across both studies and were considered exploratory.

Enrollment of both trials was completed in less than 13 months following randomization of the first patient into the program in late April 2006. Ninety-seven percent (97%) of all patients in the two CAPACITY studies who were living and had not received a lung transplant, completed their Week 72 study visit.

Each trial in CAPACITY was designed to have greater than 95% statistical power to detect a 50% reduction in the rate of FVC progression compared to placebo after 72 weeks of treatment and greater than 85% statistical power to detect a 40% reduction after the same period, when compared to placebo. The pre-specified secondary endpoints of CAPACITY were:

        1.  Time to worsening of IPF, defined as time to acute IPF
            exacerbation, IPF-related death, lung transplant or respiratory
            hospitalization, whichever comes first
        2.  Progression-free survival defined as time to the first occurrence
            of either of the following (as compared to the patient's
            baseline):
              --  10% absolute decline in percent predicted FVC, or
              --  15% absolute decline in percent predicted Hb-corrected
        
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SOURCE  InterMune
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