AstraZeneca’s benralizumab reduces asthma exacerbations in phase III trials


Benralizumab met its primary endpoint of reducing asthma exacerbations in patients with uncontrolled severe eosinophilic asthma in two phase III trials, developer AstraZeneca reported in May 2016. The monoclonal antibody (mAb) benralizumab targets the IL -5 receptor to directly deplete eosinophils, and is hoped to show better clinical benefit compared with competitor biologics. AstraZeneca plans to use these data in regulatory filings in the US and the EU in the second half of 2016. If successful, benralizumab will provide AstraZeneca with access to the severe asthma market, which certain analysts have forecast could grow to be worth more than $7 billion a year. Thomson Reuters Cortellis for Competitive Intelligence lists benralizumab worldwide Consensus Forecast sales as $466.50 million in 2021.

Benralizumab: an eosinophil-depleting anti-IL-5 receptor mAb

The recent phase III benralizumab data demonstrated significant reductions in the annual asthma exacerbation rate compared with placebo. Prof Mark FitzGerald, Director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute and Principal Investigator in the CALIM A trial, said: “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.” The registrational phase III CALIM A and SIROCCO trials, part of AstraZeneca’s WIND WARD program, evaluated two dose regimens of subcutaneous benralizumab as an add-on to high-dose inhaled corticosteroids plus long-acting beta2 agonists in 2511 patients with severe uncontrolled asthma with eosinophilic inflammation. Full results from CALIM A and SIROCCO will be reported at a conference later in 2016.

In a phase II b study, benralizumab versus placebo significantly reduced asthma exacerbations by approximately 40 to 70% and significantly improved lung function and asthma symptoms in patients with uncontrolled eosinophilic asthma. High blood eosinophil counts were shown to be predictive of exacerbation rate reduction by benralizumab. In a randomized, phase II study in 110 patients who had required a hospital visit for treatment of an acute asthma exacerbation, benralizumab reduced exacerbation rates by 49% and exacerbations resulting in hospitalization by 60%. Data from a phase I study in 13 adults with eosinophilic asthma showed the drug reduced eosinophil counts in airway mucosa/submucosa and sputum, and suppressed eosinophil counts in bone marrow and peripheral blood.

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