AstraZeneca’s benralizumab meets main goals in phase III trials for severe asthma

In the trials, dubbed Sirocco and Calima, a total of 2,511 patients who were receiving standard-of-care therapy, including inhaled corticosteroids and long-acting beta 2 agonists, were randomized to receive either 30 mg of benralizumab every four weeks; 30 mg of benralizumab every four weeks three times followed by 30 mg every eight weeks; or placebo for 48 weeks.

The eight-week benralizumab regimen showed a reduction in the annual rate of asthma exacerbations of up to 51% and an improvement in lung function (measured by FEV1 of up to 159 mL) after four weeks of therapy that was sustained throughout the treatment period.

Improvement in asthma symptoms like cough, wheeze, chest tightness and shortness of breath was also observed.

No additional benefit was seen with the 4-week regimen which could support less-frequent dosing.

AstraZeneca said the adverse event frequency was same between the benralizumab-treated cohorts and placebo.

The company will include data from both studies in regulatory submissions in the US and EU later this year.

AstraZeneca executive vice president of global medicines development and chief medical officer Sean Bohen said the phase III trials have demonstrated 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.”

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Image: Benralizumab phase III trials show positive results in severe asthma.  Photo: courtesy of AstraZeneca.