- CAPACITY 2 Meets Primary and Key Secondary Endpoints -
- CAPACITY 1 Misses Primary Endpoint, Provides Supportive Data -
- Company Preparing to Submit NDA and MAA -
BRISBANE, Calif., Feb. 3 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from the two Phase 3 CAPACITY studies evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).
The primary endpoint of change in percent predicted Forced Vital Capacity (FVC) 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 (PFS). 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 (NDA) for submission to the FDA, to be followed by a Marketing Authorization Application (MAA) submission to the EMEA.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "We are very pleased by the overall efficacy and safety of pirfenidone in the treatment of IPF provided by the two CAPACITY studies. In CAPACITY 2, pirfenidone demonstrated a robust treatment effect on the primary endpoint and key secondary endpoints. Although the effect of pirfenidone did not achieve statistical significance on the primary endpoint in CAPACITY 1, the overall treatment effect of pirfenidone was in many respects similar in both studies. The totality of the data from these two studies suggests that pirfenidone has a positive treatment effect on patients with IPF. We believe that the efficacy data from both of the CAPACITY studies as well as Shionogi's Phase 3 stu
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