InterMune completes enrollment of phase 3 Inspire trial

By Elaine Rigoli

Tampa, Fla., April 18 - InterMune, Inc. said it completed patient enrollment on Thursday in the Inspire trial, a phase 3 clinical trial of Actimmune (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF).

Actimmune is not approved for the treatment of IPF.

The trial is anticipated to conclude in late-2007 and top-line data are expected in early 2008, the company said in a news release.

Inspire is a randomized double-blind, placebo controlled 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, the release said.

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 a placebo, respectively.

Several peer-reviewed publications regarding Actimmune for the treatment of patients with IPF support the hypothesis upon which the Inspire trial was designed, the release said.

Based in Brisbane, Calif., InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology.

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