InterMune completes enrollment in Ph III Actimmune trial

US drugmaker InterMune has completed patient enrollment in the INSPIRE trial, a pivotal Phase III clinical evaluation of Actimmune (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis, an ultimately fatal breathing disorder that affects approximately 83,000 people in the USA.

The trial is expected to conclude late next year and top-line data are expected in early 2008. The randomized double-blind, placebo-controlled Phase III study is designed to evaluate the safety and efficacy of the agent in IPF patients with mild-to-moderate impairment in lung function and its primary endpoint is survival time. 826 patients were enrolled at 81 sites in North America and Europe. Patients were randomized at a ratio of 2:1 to receive either 200mcg of Actimmune subcutaneously three times per week or placebo.