AstraZeneca says its respiratory biologic meets primary endpoint in Phase III trial
UK-based AstraZeneca (LSE: AZN) on Tuesday said late stage trials for its biologic asthma drug met the primary endpoint.
Chief Medical Officer Sean Bohen said, top-line results from these pivotal trials demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma.
Benralizumab is AstraZeneca’s first respiratory biologic.
The trials evaluated the efficacy and safety of benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.
Mark FitzGerald, principal investigator in the trial, said: “We are learning more about different sub-types of asthma, and these trials investigate a potential new treatment to address the underlying driver for some patients. 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.”
Regulatory submissions in the US and EU are anticipated in the second half of 2016, the company said in a statement.
Eosinophils are the biological effector cells that drive inflammation and airways hyper-responsiveness in about 50% of asthma patients, leading to frequent exacerbations, impaired lung function and reduced quality of life.
Benralizumab is an anti-eosinophil monoclonal antibody that depletes eosinophils via antibody‐dependent cell-mediated cytotoxicity (ADCC), the process by which natural killer cells are activated to target eosinophils. Benralizumab induces direct, rapid, and near complete depletion of eosinophils in the bone marrow, blood and target tissue.
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