Temple University Hospital served as a key investigative site for two international phase III clinical trials that found asthma drug benralizumab is not effective in reducing exacerbations for patients with moderate to very severe COPD.
What is COPD?
Chronic obstructive pulmonary disease (COPD) afflicts more than 15.3 million people in the U.S. alone. It is the third leading cause of death in the nation, according to the American Lung Association. It is an umbrella term to describe progressive lung diseases including emphysema, chronic bronchitis, and refractory (non-reversible) asthma. The disease is characterized by increasing breathlessness.
Patients often experience potentially life-threatening exacerbations, which can include days-long flare-ups of symptoms including shortness of breath that occur when the airways narrow from muscle tightness, swelling and mucus.
The Benralizumab Study (GALATHEA & TERRANOVA)
Temple participated in a study recently for which the results where recently published in the New England Journal of Medicine May 20. The study was sponsored by industry sponsor AstraZeneca (Medimmune). Temple reported that the drug benralizumab failed to decrease annual COPD exacerbation rates for patients with moderate to severe COPD, a history of frequent and/or severe exacerbations, and eosinophilic inflammation (when a type of white blood cells knowns as eosinophils build up in one location and is associated with an increased exacerbation risk).
The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbation in patients with moderate to severe COPD, eosinophilic inflammation, and increased risk of exacerbations.
More than 3,000 patients aged 40-85 participated in the study across two studies and hundreds of research sites around the world. Patients received placebo or benralizumab via subcutaneous injection every 4 weeks for the first three doses, thereafter, every 8 weeks during the 56-week treatment period.
What is Benralizumab? (Fasenra)
It is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma. AstraZeneca’s global biologic research and development arm Medimmune.
Two Phase III trials of benralizumab, SIROCCO and CALIMA, reported meeting their primary endpoints in 2016. It was consequently approved by the U.S. FDA in November, 2017 for the treatment of severe eosinophilic asthma.
Research Sites Referred
- Temple University (issued press release)
- Brigham and Women’s Hospital, Harvard Medical School (led study)
Dr. Gerard J. Criner, MD, FACP, FACCP, Chair & Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine, Temple University