AEROVANCE REPORTS POSITIVE PHASE II DATA ON ASTHMA DRUG
Aerovance announced positive top-line results from a Phase IIa trial of inhaled Aerovant in asthma patients. The 30-patient antigen challenge study met its primary endpoint of reducing the severity of late asthmatic response by a statistically significant 72 percent compared with baseline following the twice-daily use of inhaled Aerovant (IL-4 and IL-13 antagonist) for 27 days.
The study also met the secondary endpoint of decreasing the forced expiratory nitric oxide in patients, indicating a reduction in airway inflammation.
Conducted in the UK, the Phase IIa trial was a randomized, double-blind, parallel-group, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course of inhaled Aerovant. Thirty patients with mild to moderate asthma were randomized to receive 60 mg of nebulized Aerovant or volume-matched placebo administered twice daily.
Aerovant is a recombinant human IL-4 variant that is a potent inhibitor of both the IL-4 and IL-13 receptors. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer in 2004.