The phase IIa trial was designed to assess the safety and efficacy of a 28-day treatment course of inhaled Aerovant.
The study met its primary endpoint of reducing the severity of late asthmatic response by a statistically significant 72% compared to baseline following the twice-daily use of inhaled Aerovant 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.
“Through the inhibition of the IL-4 and IL-13 receptors, Aerovant targets the mechanism that is one of the root causes of asthma and other atopic diseases. We plan to initiate a phase IIb study with a dry powder inhalation formulation in uncontrolled asthma patients later this year,” said Rick Fuller, Aerovance’s executive vice president and COO.
Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals in 2004.