News Feature | September 11, 2014

AZ Posts Benralizumab Phase II Results In COPD

By Estel Grace Masangkay

AstraZeneca presented the latest results from its Phase IIA study investigating benralizumab in patients with chronic obstructive pulmonary disease (COPD). The study was conducted by AZ’s global biologics R&D arm MedImmune.

Benralizumab is a humanized monoclonal antibody that targets the alpha sub-unit of the interleukin-5 receptor (IL-5Rα). IL-5Rα has been shown to deplete eosinophils, an important target cell in inflammatory respiratory disease that is linked with respiratory disease exacerbations.

The Phase IIA study assessed the efficacy and safety of benralizumab in over 100 adult patients with moderate to severe COPD who have suffered at least one acute disease exacerbation that required treatment. AZ reported that the study did not meet its primary endpoint of superiority over placebo, however the drug was able to enhance lung function in the overall patient population in the trial.

While the study’s findings were deemed disappointing by some, AZ emphasized that the trial yielded other positive results. Pre-specified analyses showed benralizumab improved disease symptoms, including significant reduction in COPD exacerbations in some patient groups, especially those who had higher baseline levels of eosinophils. Eosinophilic airway inflammation is thought to occur in 20 to 30 percent of the 210 million COPD patients around the world.

“Benralizumab is the first biological agent to show marked reduction in eosinophilic inflammation and beneficial effects in COPD, indicating a potential new way to treat patients with severe COPD symptoms,” said principal investigator Professor Christopher Brightling, University of Leicester, Glenfield Hospital, Department of Respiratory Medicine. Professor Brightling added that the results merit further investigation of the drug for COPD.

Bing Yao, SVP and Head of MedImmune’s Respiratory, Inflammation, and Autoimmunity Innovative Medicines Unit, said, “Respiratory disease is a core therapeutic area for AstraZeneca and we are encouraged by these results indicating benralizumab’s potential to help certain groups of patients. We look forward to the further development of this promising new biologic as we progress our Phase III programs in both COPD and severe asthma.”

The study results were published in The Lancet Respiratory Medicine.