Benralizumab demonstrated significant reductions in the annual asthma exacerbation rate compared to placebo.
The trials, Sirocco and Calima, assessed the safety and efficacy of two dose regimens of benralizumab as add-on therapy for serious uncontrolled asthma with eosinophilic inflammation in patients at least 12 years old.
A total of 2,511 patients received benralizumab 30mg every four weeks; 30mg every four weeks for the initial three doses followed by 30mg every eight weeks; or placebo.
The primary analysis population included patients on high-dose inhaled corticosteroids and long-acting ß2-agonist with a baseline blood eosinophil count of more than 300 cells/microliter.
AstraZeneca executive vice president of global medicines development and chief medical officer Sean Bohen said: "We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma.
"Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory disease with our next generation of respiratory medicines."
Benralizumab is also in phase III development to treat chronic obstructive pulmonary disease.
Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor that depletes eosinophils, an important target cell in inflammatory respiratory disease.
AstraZeneca in-licensed benralizumab from BioWa, a subsidiary of Kyowa Hakko Kirin.
Kyowa Hakko Kirin/BioWa have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia, while AstraZeneca holds exclusive rights in all other countries including the US and Europe.
Image: Benralizumab demonstrated significant reductions in the annual asthma exacerbation rate compared to placebo. Photo: courtesy of AstraZeneca.