AstraZeneca announces positive results for benralizumab phase 3 trial for asthma

AstraZeneca announced that benralizumab achieved its primary endpoint in two phase 3 trials, according to a press release.

Benralizumab, an anti-eosinophil monoclonal antibody, was well tolerated and showed reduced annual asthma exacerbation rates when compared with placebo in the SIROCCO and CALIMA trials.

“Severe asthma affects the health and quality of life of millions of people around the world, and exacerbations can be life threatening for these patients," Sean Bohen, executive vice president of global medicines development and chief medical officer, said in the release. "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.”

According to the press release, CALIMA and SIROCCO were randomized, double-blind, parallel group, placebo-controlled trials to assess the safety and efficacy of benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation.

Researchers in the trials analyzed patients aged 12 and older who were on high-dose inhaled corticosteroids and long-acting β2-agonist and had a baseline blood eosinophil count ≥ 300 cells/µL.

The studies included 2,511 patients who were randomly assigned to placebo or one of two benralizumab regimens: 30 mg every 4 weeks or 30 mg every 4 weeks for three doses and then 30 mg every 8 weeks. AstraZeneca reported that safety and tolerability in these trials were comparable to findings from previous trials.

“We are learning more about different subtypes of asthma, and these trials investigate a potential new treatment to address the underlying driver for some patients," Mark FitzGerald, MD, director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute and principal investigator in the CALIMA trial, said in the release. "Within the appropriate patient population, the anti-eosinophil effect of benralizumab has the potential to deliver uniquely-targeted treatment for patients whose asthma is driven by eosinophilic inflammation.”

AstraZeneca will present results from the two trials at a future medical meeting, according to the release. The company plans regulatory submissions in both the United States and the European Union in 2016.

AstraZeneca is also investigating benralizumab in patients with chronic obstructive pulmonary disease in another phase 3 trial.