AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.
The two trials, SIROCCO and CALIMA, are both part of the comprehensive WINDWARD program for benralizumab in asthma, the largest Phase 3 program for a biologic in respiratory disease, comprising 6 total Phase 3 studies. Both trials are randomized, double-blind, parallel group, placebo-controlled studies evaluating the efficacy and safety of benralizumab vs. placebo in a total of 2,511 patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids (ICS) plus long-acting β2-agonist (LABA) with or without oral corticosteroid (OCS) and additional asthma controllers. Patients either received benralizumab 30mg SC every 4 weeks, 30mg SC every 4 weeks for the first 3 doses followed by 30mg every 8 weeks, or placebo. The primary endpoint was reduction in the annual asthma exacerbation rate.
Both trials demonstrated significant reductions in the annual asthma exacerbation rate for benralizumab compared to placebo. In addition, benralizumab showed a tolerable safety profile that was consistent with findings from previous trials. Detailed results for both the SIROCCO and CALIMA trials will be presented at a future medical meeting. AstraZeneca anticipates regulatory submission to the FDA in the second half of 2016.
Additional trials for benralizumab are underway, including the Phase 3 VOYAGER study designed to evaluate its efficacy and safety in patients with severe chronic obstructive pulmonary disease (COPD).
Benralizumab is a novel anti-eosinophil monoclonal antibody for use as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.
For more information call (800) 237-8898 or visit Astrazeneca.com.