Aerovant misses asthma endpoint

Aerovance Inc. (Berkeley, Calif.) said all three doses of inhaled Aerovant missed the primary endpoint of significantly reducing the incidence of asthma exacerbations vs. placebo in the Phase IIb AeroTrial to treat moderate to severe asthma. However, in a pre-defined subset of 125 patients with eosinophilic asthma, the incidence of asthma exacerbations was significantly lower for one and 10 mg twice-daily Aerovant vs. placebo (18% and 13%, respectively, vs. 50%, p<0.006 and p<0.004). The double-blind, dose-ranging, U.S. and European trial enrolled 534 patients inadequately controlled on the combination of inhaled corticosteroids and long-acting beta-2 adrenergic agonists (LABAs). Patients received one, three or 10 mg Aerovant or placebo twice daily for 12 weeks. Aerovant is a recombinant human IL-4 variant that inhibits both IL-4 and IL-13 receptors. ...