InterMune (ITMN) Up After Positive Phase 3 CAPACITY Studies of Pirfenidone in IPF
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InterMune, Inc. (Nasdaq: ITMN) is higher in pre-open trading after the company announced results from the two Phase 3 CAPACITY studies evaluating pirfenidone in patients with idiopathic pulmonary fibrosis.
The primary endpoint of change in percent predicted Forced Vital Capacity at Week 72 was met with statistical significance in CAPACITY 2 (p=0.001), along with the secondary endpoints of categorical change in FVC and progression-free survival. The primary endpoint was not met in CAPACITY 1 (p=0.501), but supportive evidence of a pirfenidone treatment effect was observed on a number of measures. Pirfenidone was safe and generally well tolerated in both CAPACITY studies. The company is preparing a New Drug Application for submission to the FDA, to be followed by a Marketing Authorization Application submission to the EMEA.
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