Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrol...( BERKELEY Calif. March 2 /- Aerovance ...),Health

BERKELEY, Calif., March 2 /PRNewswire/ -- Aerovance Inc. today 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by inhalation twice daily for 12 weeks, during which time their standard ICS and LABA therapies will be gradually withdrawn.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
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