Actimmune misses hurdle, but gains gold

Missing the primary endpoint in Phase III trials usually spells doom for investigational drugs, but this might not be the case for Actimmune interferon gamma-1b from InterMune Inc. in idiopathic pulmonary fibrosis (IPF). The product failed to significantly reduce the time to disease progression, the primary endpoint in its Phase III study. However, Actimmune increased patient survival time, an endpoint that could be considered more clinically relevant, given that IPF is a fatal disease.

In the double-blind trial in 330 patients, Actimmune gave about a 10% relative reduction in disease progression compared to placebo (46.3% rate of progression vs. 51.8%, p=0.5). Progression was defined as a decrease in one of two measures of pulmonary function, or death...