Intermune has completed patient enrollment in the INSPIRE trial, a pivotal Phase III clinical trial of Actimmune (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF). The trial is anticipated to conclude in late 2007 and top-line data are expected in early 2008. At this time, Actimmune is not approved for the treatment of IPF.
INSPIRE is a randomized double-blind, placebo controlled Phase III study designed to evaluate the safety and efficacy of Actimmune in IPF patients with mild to moderate impairment in lung function. The primary endpoint of the trial is survival time. A total of 826 patients were enrolled at 81 sites in North America and Europe. Patients were randomized at a ratio of 2:1 to receive either 200 micrograms of Actimmune subcutaneously three times per week or placebo, respectively.