Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.
The SIROCCO and CALIMA trials evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens as add-on therapy to standard-of-care medicine across primary and key secondary endpoints. Results showed: Reductions in the annual rate of asthma exacerbations (up to 51%), Improvement in lung function (change in FEV1 of up to 159 mL), which was seen at 4 weeks after the first benralizumab dose and sustained throughout the treatment period, Improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath
The outcomes were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. Detailed results were published in The Lancet.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, 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 with severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.”
Benralizumab is an anti-eosinophil monoclonal antibody that induces direct, rapid and near-complete depletion of eosinophils, with an onset of action within 24 hours as confirmed in early phase I/II trials. Eosinophils are the biological effector cells that drive inflammation and airway hyper-responsiveness in approximately 50% of asthma patients, leading to frequent exacerbations, impaired lung function and asthma symptoms.
The data from the SIROCCO and CALIMA trials will be included in regulatory submissions for benralizumab that are planned for the US and EU later in 2016.
