- Company Initiates Phase 2a Trial in Patients with Stable Asthma and
Exercise-Induced Bronchoconstriction -
GAITHERSBURG, Md., March 18 /PRNewswire/ -- MedImmune today announced that its clinical program studying an investigational treatment targeting interleukin-9 (IL-9) has advanced with the start of a new trial in patients with asthma. The company initiated a Phase 2a clinical trial designed to assess the potential of its anti-IL-9 monoclonal antibody (MAb), MEDI-528, in patients with stable asthma and exercise-induced bronchoconstriction. This trial is the fourth study of this antibody in patients with asthma.
"Commencing this trial is a promising step in the clinical development of MEDI-528, as preclinical data has suggested that blocking IL-9 may provide clinical benefit for patients with asthma," said Barbara White, vice president, clinical development, inflammatory disease. "We look forward to continuing to work with our network of collaborative researchers to discover and assess novel pathologies and approaches to inflammatory diseases."
The goal of this clinical trial is to assess the safety and tolerability of multiple fixed escalating doses of MEDI-528 in adult patients with stable asthma and exercise-induced bronchoconstriction. The study will also assess the effect of the antibody on exercise challenge testing, as well as the pharmacokinetics and immunogenicity of the investigational treatment. Enrollment of this randomized, double-blind, placebo-controlled trial has commenced at Northeast Medical Research Associates, Inc. and the study is expected to expand to additional sites throughout the United States and Canada. Preliminary safety results from an ongoing Phase 2 trial support the continued development of the antibody in patients with mild-to-moderate asthma.
IL-9 has been associated with symptoms of asthma. It is one of at least 29 naturally occurring interleukins in the human body. Overexpression of IL-9 in animal models has been shown to result in many features of asthma, including increased airway inflammation and hyperreactivity. Blocking the actions of IL-9 has been shown to reduce the increased airway inflammation and airway hyperresponsiveness seen in animal models of asthma. MedImmune is conducting research to evaluate the potential to use MAbs targeting IL-9 to treat or prevent symptomatic, moderate-to-severe, persistent asthma.
Asthma is a chronic disease of the airways that may cause wheezing, breathlessness, chest tightness and coughing. According to the U.S. Centers for Disease Control and Prevention (CDC), more than 30 million Americans reported having a history of asthma in 2003, including nine million children. About 20 million said they currently had asthma. In 2000, the CDC reported that there were more than 10 million asthma-related outpatient visits to private physician offices and hospital clinics. The National Institutes of Health (NIH) have estimated asthma-related healthcare costs in the U.S. at $14 billion annually.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on cardiovascular/gastrointestinal disease, neuroscience, oncology, infection, respiratory disease and inflammation. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
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