AstraZeneca's benralizumab reduces asthma exacerbations up to 51% in two late-state studies

Sep. 05, 2016 3:39 PM ETAstraZeneca PLC (AZN)AZNBy: Douglas W. House, SA News Editor
  • Two Phase 3 clinical trials, SIROCCO and CALIMA, assessing two dosing regimens of AstraZeneca's (NYSE:AZN) interleukin-5 inhibitor, benralizumab, as add-on therapy in patients with severe eosinophilic asthma met their primary and secondary endpoints. The data were presented at the European Respiratory Society International Congress in London. Detailed results were published today in The Lancet.
  • A total of 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA) 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 was also observed.
  • No additional benefit was seen with the 4-week regimen which supports less-frequent dosing.
  • The incidence of adverse events was similar between the benralizumab-treated cohorts and placebo.
  • The data from both studies will be included in regulatory submissions in the U.S. and EU later this year.
  • Previously: AstraZeneca's asthma candidate benralizumab successful in two late-stage studies (May 17)

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