Aftermarket News: InterMune Discontinues Phase 3 INSPIRE Trial of Actimmune in Idiopathic Pulmonary Fibrosis

InterMune, Inc. today announced that it has discontinued the Phase 3 INSPIRE clinical trial evaluating Actimmune(R) (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF) based upon the recommendation of the study's independent data monitoring committee (DMC). In a planned interim analysis that included a total of 115 deaths, the DMC found the overall survival result crossed a predefined stopping boundary for lack of benefit of Actimmune(R) relative to placebo. Among the 826 randomized patients, there was not 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). Based on a preliminary review of the interim safety data, the adverse events associated with Actimmune(R) therapy appear generally consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.

INSPIRE was a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Actimmune(R) in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time. The lack of benefit stopping boundary was developed to allow for early study termination in the event interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune(R). InterMune plans to submit the data from the Phase 3 INSPIRE trial for presentation at an appropriate medical meeting and for publication in a peer-reviewed journal.

"The interim results of the INSPIRE trial and our decision to discontinue the trial are disappointing," said Steve Porter, M.D., Ph.D., Chief Medical Officer at InterMune. "We are extremely grateful for the strong support we received from physicians, healthcare providers and especially the patients who participated in the clinical evaluation of Actimmune(R). The overall conduct of the study by investigators and the participation by patients were exemplary."

Nasdaq: ITMN in after hours trading is down 18.7% down 5.25 dollars per share at $22.80. OUCH!

Actimmune is a human cytokine termed Interferon gamma-1b being used to treat idiopathic pulmonary fibrosis (that is an inflammatory lung disorder of unknown origin characterized by abnormal formation of fibrous tissue between the tiny air sacs of the lungs. ) IFN-1b acts as a potent stimulator of the immune system.