AstraZeneca (AZN.L,AZN) said it has begun the Phase III Windward programme for benralizumab, a potential treatment for severe uncontrolled asthma developed by MedImmune, the company's global biologics research and development arm. The aim of CALIMA, the first trial in the Windward programme, is to determine whether benralizumab reduces the number of exacerbations in patients with severe asthma that remains uncontrolled, despite receiving high doses of inhaled corticosteroids combined with a second controller like long-acting beta agonist.
Benralizumab is a monoclonal antibody binding to the interleukin-5 receptor, that depletes eosinophils, a type of white blood cell, which play a critical role in the cause and severity of asthma and asthma exacerbations. Emerging evidence demonstrates that for patients with elevated eosinophil counts, treatment with an IL-5 inhibitor in addition to guideline-based strategies may increase their asthma control and decrease the frequency of asthma attacks.
The CALIMA trial would evaluate the safety and effectiveness of benralizumab in actively reducing exacerbations in patients with uncontrolled asthma, and assess the benralizumab effect on lung function, asthma symptoms and other asthma control measures, as well as emergency room and hospitalisation rates due to asthma.
The efficacy and safety data from this trial supported the progression of benralizumab into our Phase III programme. These results are likely to be shared at a scientific conference in the first half of 2014. Benralizumab is in-licensed from BioWa, Inc., a subsidiary of Kyowa Hakko Kirin Co., Ltd.
by RTT Staff Writer
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