AstraZeneca has reported positive data from its Phase III trials of benralizumab combined with standard care for the treatment of severe asthma.
Benralizumab is developed as a humanised monoclonal antibody directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα) that affects eosinophils.
Eosinophils are the biological effector cells triggering inflammation and airway hyper-responsiveness and resulting in frequent exacerbations, impaired lung function and asthma symptoms.
The SIROCCO and CALIMA trials are a part of the WINDWARD programme intended as a development programme for biologic medicine in respiratory disease.
The randomised, double-blind, parallel-group, placebo-controlled SIROCCO and CALIMA trials involved a total of 2,511 patients.
The trials were designed to test the efficacy and safety of a regular, subcutaneous administration of benralizumab as a test of the efficacy of benralizumab in two dosing regimens administered over four weeks, and was examined as an add-on therapy to the standard care over a period of eight weeks.
Results displayed reduced asthma exacerbations and improved lung function after four weeks of dosage of benralizumab, with improvement noted in asthma symptoms such as wheezing, coughing, chest tightness and shortness of breath.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen said: “Severe asthma affects the lives of millions of patients around the world and can be life threatening.
“The SIROCCO and CALIMA Phase III trials have shown that benralizumab can offer a meaningful treatment option for patients as evidenced by reductions in exacerbations, improvement in lung function and symptoms, with the promise of fewer doses a year.
“Benralizumab has a unique way of working in patients affected by severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.”
The company is also undertaking the Phase III VOYAGER programme to test the safety and efficacy of benralizumab to treat severe chronic obstructive pulmonary disease (COPD).