Biotech Tracker: InterMune’s INSPIRE Trial Underway

Biotech Tracker: InterMune’s INSPIRE Trial Underway

December 16, 2003 The first study subject has been enrolled in InterMune’s (NASDAQ: ITMN) INSPIRE trial, a pivotal phase III trial evaluating Actimmune (interferon gamma-1b) for idiopathic pulmonary fibrosis (IPF). INSPIRE is a 600-patient, randomized, double-blind, placebo-controlled investigation of Actimmune’s therapeutic effects for IPF patients with mild-to-moderate lung function impairment. The primary endpoint of the trial is survival. Subjects will be randomized 2:1 to receive either Actimmune 200 micrograms three times a week or placebo. Each enrollee will be followed for at least 24 months.

Actimmune has consistently generated controversial data sets, kindling debate over its clinical and commercial merit. We continue to view its probability for use expansion followed by eventual label expansion into IPF as moderately above average. A significant proportion of phase III investigation designed to support label expansion reinforces the idea that statistical and clinical significance can be uncoupled. The lower the number of incident, prevalent, or studied cases, the more likely are statistically insignificant trends to be clinically significant. Conversely, the greater the number of incident, prevalent, or studied cases, the less likely statistical significance conveys clinical significance.

Given that magnitudes of therapeutic effects often drive use decisions more so than statistical significance, Actimmune’s therapeutic profile remains reassuring in IPF, especially for the survival of patients with mild-to-moderate lung function impairment, and to a lesser extent for their disease progression. For real-world decision-making, clinicians are more likely to look at these magnitudes of effects (measured as relative risk reductions in the relevant, phase III data sets), especially given that Actimmune is already marketed for other indications.

In spite of this positive outlook, an interesting observation from data presented at last May’s American Thoracic Society meeting is that survival is preserved without an increase in quality of life, ability to breath more comfortably, or ability to decrease reliance on medicinal oxygen. The failure of the study to demonstrate that one’s life, although extended, gets considerably more appealing, is most likely an issue of use ceilings than it is of label expanding potential. The use of Actimmune to extend life without enhancing its quality or reducing specific medical resource burdens will only be acceptable to a limited population of patients, providers, and payors.

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