Aerovance enrolls 540 patients in Phase 2b Aerovant clinical trial

Aerovance Inc. today announced it has completed patient enrollment in a Phase 2b clinical trial of the inhaled dry powder formulation of Aerovant for the treatment of uncontrolled asthma. Top-line results are expected by the second quarter of 2010.

Named AeroTrial(TM), the study enrolled approximately 540 patients at 75 sites in the United States and Europe. In the double-blind, randomized, placebo-controlled, dose-ranging trial, patients with moderate to severe asthma who were inadequately controlled on the combination of inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) were assigned to receive one of three Aerovant doses (1 mg, 3 mg or 10 mg) or placebo by inhalation twice daily for 12 weeks. During this time the standard ICS and LABA therapies were withdrawn gradually. The trial's primary endpoint is the incidence of asthma exacerbations on Aerovant therapy as compared to placebo. Secondary endpoints include pulmonary function, time to exacerbation, daily peak expiratory flow (PEF) and symptom scores, immunoglobulin E (IgE) levels and fractional concentration of expired nitric oxide (FeNO).

"We have reached a significant milestone in the development of Aerovant," said Mark Perry, Aerovance's president and chief executive officer. "We anticipate completing dosing of all patients in early 2010 and expect top-line data to be available by the second quarter of 2010, at which time Aerovance will resume discussions with potential corporate partners for the further development of Aerovant."

Aerovant is a recombinant human IL-4 variant that is a potent inhibitor of both IL-4 and IL-13 activity. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corporation in 2004.