The Lancet has published data from two trials of AstraZeneca's biologic benralizumab showing that the drug significantly reduced exacerbations and improved lung function and symptoms in patients with severe eosinophilic asthma.
The drugs giant said earlier this year that the Phase III SIROCCO and CALIMA trials - which assessed the drug as an add-on to standard-of-care in four- and eight-week regimens - met primary and key secondary endpoints.
Results show reductions in the annual rate of asthma exacerbations of up to 51 percent, and an improvement in lung function with a change in FEV1 of up to 159 mL, seen at four weeks after the first benralizumab dose and sustained throughout the treatment period.
Also of note, there was an improvement in asthma symptoms such as wheeze, cough, chest tightness and shortness of breath, and the adverse event frequency was similar between benralizumab-treated patients and those in the placebo arm in both trials.
The outcomes were observed for the eight-week regimen, with no additional benefit seen with the more frequent regimen, which may support less frequent dosing, the firm noted, and said the data will be included in regulatory submissions planned for both the US and EU later this year.
Benralizumab is an anti-eosinophil monoclonal antibody that induces direct, rapid and near-complete depletion of eosinophils, which drive inflammation and airway hyper-responsiveness in around 50 percent of asthma patients, with an onset of action within 24 hours as confirmed in early Phase I/II trials.
The drug is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin. Under the exclusive license agreement, the firms have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AZ has exclusive rights for the drug in all other countries including the US and Europe.