Aerovance Announces Positive Top-Line Results From Phase 2a Trial Of Inhaled AEROVANT(TM) In Asthma Patients

Aerovance, Inc. today announced positive top-line results from a Phase 2a trial of inhaled AEROVANT(TM) 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 (p<0.001) compared to baseline following the twice- daily use of inhaled AEROVANT(TM) (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. Aerovance plans to present the full study results at a scientific conference later this year.

“These are very promising data that show the clear-cut effects of inhaled AEROVANT(TM) in asthma patients,” said Rick Fuller, M.D., Ph.D., Aerovance’s executive vice president and chief operating officer. “Through the inhibition of the IL-4 and IL-13 receptors, AEROVANT(TM) targets the mechanism that is one of the root causes of asthma and other atopic diseases. We plan to initiate a Phase 2b study with a dry powder inhalation formulation in uncontrolled asthma patients later this year.”

Mark Perry, Aerovance’s executive chairman, added: “We are pleased with the results of this study and look forward to advancing our development of AEROVANT(TM). Based on these data, we are initiating strategic partnership discussions for this product.”

Conducted in London, the Phase 2a 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(TM). Thirty patients with mild to moderate asthma were randomized to receive 60 mg of nebulized AEROVANT(TM) or volume-matched placebo administered twice daily.

AEROVANT(TM) 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 Pharmaceuticals Corp. in 2004.

Aerovance, Inc. is a Berkeley, Calif.-based biopharmaceutical company focused on the development and commercialization of breakthrough therapies for the treatment of respiratory and inflammatory diseases.

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