Phase IIa study results for benralizumab in COPD published in The Lancet Respiratory Medicine-AstraZeneca

AstraZeneca announced that The Lancet Respiratory Medicine has published encouraging safety and efficacy data from a Phase IIa study evaluating its novel investigational monoclonal antibody benralizumab in patients with Chronic Obstructive Pulmonary Disease (COPD). The study, conducted by MedImmune, the company�s global biologics research and development arm, evaluated the safety and efficacy of benralizumab in 101 adults with moderate-to-severe COPD and experiencing at least one acute exacerbation requiring oral corticosteroids, antibiotics, or hospitalisation in the past year. The overall patient population for the study was selected on the basis of elevated levels of eosinophils in sputum. The primary endpoint in the study was not met, as benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall patient population.

However, benralizumab demonstrated clinically significant improvements in lung function in the overall population. In addition, in the pre-specified analyses, the study indicated that benralizumab reduced COPD exacerbations and improved other symptoms of COPD in certain patient groups. Patients treated with benralizumab who had higher baseline levels of eosinophils in their blood showed greater improvements in COPD symptoms, including exacerbation rate, lung function and disease-specific health status as measured by the Saint George�s Respiratory Questionnaire-COPD (SGRQ-C) versus placebo-treated subjects.

There was a higher incidence of serious treatment-emergent adverse events (TEAEs) in the benralizumab group compared with placebo (14 vs 9). Overall, TEAEs were similar across treatment and placebo groups.These data will be presented in a poster session at the 2014 European Respiratory Society (ERS) International Congress in Munich, Germany, on 8 September 2014, along with key data from AstraZeneca�s broad respiratory portfolio.