September 8, 2014
By Mark Terry, BioSpace.com Breaking News Staff
AstraZeneca PLC announced new safety and efficacy data from the results of a Phase 2a study of its drug, benralizumab, in patients with chronic obstructive pulmonary disease (COPD). The data will be published in the journal, The Lancet Respiratory Medicine and presented in a poster session at the 2014 European Respiratory Society (ERS) International Congress in Munch, Germany on September 8th, 2014.
The study was conducted by MedImmune, a division of AstraZeneca, and was designed to evaluate the safety and efficacy of benralizumab in 101 adult patients with moderate-to-severe COPD. The patients also experienced at least one acute exacerbation that required oral corticosteroids, antibiotics, or hospitalization in the last year.
The primary endpoint of the study was not met — benralizumab did not reduce the rate of acute exacerbation compared to placebo. However, the drug did show clinically significant improvements in lung function in the overall population involved in the study. Patients with higher baseline levels of eosinophils in their blood realized greater improvements in COPD symptoms. Those symptoms included: exacerbation rate, lung function, and disease-specific health status. However, there was also a higher incidence of serious treatment-emergent adverse events (TEAEs) in the patients receiving benralizumab compared to the placebo group.
Benralizumab works to deplete eosinophils in blood and sputum. Eosinophils are a type of white blood cell that are most closely associated with certain types of infections and allergy and asthma. Patients were partially selected for the study on the basis of increased eosinophil levels in sputum. The drug is an anti-interluekin-5 receptor alpha monoclonal antibody. Inflammation in the airways related to eosinophils is believed to be related to 20 to 30 percent of COPD cases worldwide.
“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 lead investigator Professor Christopher Brightling of the University of Leicester, Glenfield Hospital, Department of Respiratory Medicine, in a press release. “The strength of these results reinforces the further development of this molecule for COPD.”
The company announced in July that it was initiating a final-stage Phase III study for benralizumab in COPD. Despite its mixed mid-stage results, the company apparently sees promise in the data. Bing Yao, head of respiratory drug development for AstraZeneca’s MedImmune division, said, “COPD is a highly heterogeneous disease and we are working to better understand patient subtypes, identify potential biomarkers and tailor therapies to achieve the best outcomes for patients.”
