Phase 2b study of Aerovant for the treatment of eosinophilic asthma

Aerovance Inc. announced top-line results from its Phase 2b trial demonstrating that Aerovant (pitrakinra) is effective in a pre-defined subset of patients with eosinophilic asthma. This 534-patient, double-blind, randomized, placebo-controlled, dose-ranging study showed a 37% reduction (p < 0.004) in the incidence of asthma exacerbations in patients on Aerovant 10 mg twice daily treatment compared to placebo in the subset of patients (n = 125) with eosinophilic asthma, as measured by elevated blood eosinophils. Time to exacerbation and asthma symptom scores also improved significantly compared to placebo in the same patient population. In the broader study population of moderate to severe asthmatics (eosinophilic plus non-eosinophilic asthmatics), there was no statistically significant difference between Aerovant and placebo, although Aerovant 10 mg (highest dose) did show trends towards drug effect.

Aerovant is a dry powder for inhalation formulation for a recombinant human IL-4 variant that is a potent inhibitor of both IL-4 and IL-13 activity.

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