Aerovance starts trial of Aerovant for uncontrolled asthma

Aerovance Inc. has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate Aerovance's Phase IIb clinical trial, AeroTrial(TM), of inhaled dry powder Aerovant in patients with uncontrolled asthma.

Study initiation begins today in the United States for AeroTrial, a double-blind, randomized, placebo-controlled, Phase IIb dose-ranging study. Aerovance expects to enroll approximately 500 patients with moderate to severe asthma, in the United States and Europe, who are poorly controlled by the combination of inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). Patients will be randomly 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by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn. The primary endpoint is exacerbation incidence 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).

"Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and potentially for patients living with uncontrolled asthma. The efficacy and safety data from our completed Aerovant studies are promising, and we are pleased to begin evaluation of this compound in a large number of moderate to severe asthmatics," said Mark Perry, Aerovance's president and chief executive officer. "Aerovant targets a root cause of asthma by blocking the signaling activity of two key cytokines, interleukin-4 (IL-4) and interleukin-13 (IL-13), critical in the progression of the disease. Our Phase IIa data suggest that targeted delivery to the lung is superior to systemic administration in blocking the asthmatic activities of IL-4 and IL-13 and has the potential to provide a breakthrough treatment for a patient population with few options."

AeroTrial is a late-stage clinical study using a dry powder formulation and follows positive clinical data from two Phase IIa studies in which Aerovant demonstrated significant benefit in asthmatics who were experimentally challenged with inhaled allergen (The Lancet 2007, 370: 1422-31). The dry powder formulation that will be used in AeroTrial was well tolerated in a recently completed Phase I study in asthmatics. By using a medication based on a protein occurring naturally in the body, AeroTrial seeks a non-steroidal solution to getting control of asthma.

Aerovant is a recombinant human IL-4 variant that is a potent inhibitor of the alpha subunit of the IL-4 receptor (IL-4R alpha), a shared component of both the IL-4 and IL-13 receptor complexes. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corporation in 2004.