InterMune, Inc. has discontinued the Phase III INSPIRE trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis (IPF) based on the recommendation of an independent data monitoring committee (DMC). Interim analysis included a total of 115 deaths and the DMC found the overall survival result crossed a predefined stopping point for lack of benefit of Actimmune relative to placebo. There wasn’t a statistically significant difference between treatment groups in overall mortality (14.5% in the Actimmune group as compared to 12.7% in the placebo group). The adverse events associated with Actimmune were consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.

The randomized, double-blind, placebo-controlled trial included 826 patients and was designed to evaluate the safety and efficacy of Actimmune in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time and the lack of benefit stopping boundary allowed for early study termination in the event interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune.

Dan Welch, president and chief executive officer of InterMune, said, “Although we are disappointed by this result with Actimmune, we remain committed to addressing the significant unmet medical need in IPF with pirfenidone through our Phase III CAPACITY program. A positive treatment effect of pirfenidone on lung function has been supported in several Phase II studies and in a Phase III study as recently reported by Shionogi & Co., Ltd. We also are focused on advancing our novel hepatitis C virus drug candidate, ITMN-191. In collaboration with our partner Roche, our Phase Ia study of ITMN-191 is proceeding as planned.”