Press Releases
Aerovance Initiates Phase IIb Clinical Trial with Aerovant™ for the Treatment of Uncontrolled Asthma
BERKELEY, Calif., March 2, 2009 – 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™, 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be gradually withdrawn.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
AEROVANT 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.
Andreas Marathovouniotis or David Schull
Russo Partners
212-845-4235 or 212-845-4271
andreas.marathis@russopartnersllc.com
david.schull@russopartnersllc.com
Dave Happel
Aerovance Inc.
510-549-5525
dave.happel@aerovance.com