Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

Data from AeroTrial™, a 534-patient, double-blind, randomized, placebo-controlled, dose-ranging study, showed a 37% reduction (p < 0.004) in the incidence of asthma exacerbations in patients on Aerovant 10 mg twice daily treatment compared to placebo in the subset of patients (n = 125) with eosinophilic asthma, as measured by elevated blood eosinophils.  Time to exacerbation and asthma symptom scores also improved significantly compared to placebo in the same patient population.  In the broader study population of moderate to severe asthmatics (eosinophilic plus non-eosinophilic asthmatics), there was no statistically significant difference between Aerovant and placebo, although Aerovant 10 mg (highest dose) did show trends towards drug effect.  Overall, Aerovant was safe and well-tolerated in this study.  Aerovance plans to present a complete summary of the results at the European Respiratory Society congress in Barcelona, Spain this September.

"The data demonstrate that by inhibiting both IL-4 and IL-13, Aerovant can safely and effectively mitigate the Th2 pathway inflammation associated with high eosinophilic activity, which often leads to asthma attacks," said Sally E. Wenzel, M.D., AeroTrial principal investigator and director of the University of Pittsburgh Medical Center's Asthma Institute at the University of Pittsburgh School of Medicine. "A significant number of patients suffering from eosinophilic asthma do not respond well to current treatment with inhaled corticosteroids in combination with long-acting beta agonists.  Inhaled dry powder Aerovant may be an effective adjunctive treatment in these patients to improve asthma symptoms and prevent acute attacks."

Mark Perry, Aerovance's president and chief executive officer, added, "The results from AeroTrial provide a strong indication of Aerovant's potential to effectively and safely treat patients living with eosinophilic asthma.  We are pleased with the statistically significant results from the large subgroup of patients suffering from eosinophilic asthma.  Approximately 1 million people in the U.S. and 3.5 million people worldwide suffer from eosinophilic asthma, for which there are limited treatment alternatives.  We are a significant step closer to providing these patients with a non-steroidal treatment option that shows benefit after only 12 weeks of dosing, delivered as an inhaled dry powder as are the most widely-used asthma medications.  We are now sharing the study data with pharmaceutical companies interested in funding the continued clinical development of Aerovant."

AeroTrial was conducted at 75 sites in the United States and Europe.  In the study, 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 doses (1 mg, 3 mg or 10 mg) of Aerovant or placebo by inhalation twice daily for 12 weeks.  During this time, the standard ICS and LABA therapies were gradually withdrawn.  The trial is the largest clinical study to date of an IL-4/IL-13 inhibitor, a compound that targets a root cause of the inflammatory cascade in asthma.

Eosinophilic asthma, which can be diagnosed with a simple blood or sputum test in patients with clinical symptoms and signs of asthma, is a type of airway inflammation associated with increased levels of eosinophils, a type of white blood cell.  Patients living with eosinophilic asthma may experience changes in their airways, impaired lung function, more frequent asthma exacerbations and life-threatening asthma attacks.  Current treatment with inhaled corticosteroids in combination with long acting beta agonists is often not effective for a significant number of patients suffering from eosinophilic asthma.  Thus, an unmet healthcare need exists for an effective non-steroidal solution to control eosinophilic asthma.

Aerovant is a dry powder for inhalation formulation for 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.