AstraZeneca announced Monday that Phase III study data presented at the European Respiratory Society (ERS) international congress demonstrated that adding benralizumab to standard-of-care treatment significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype. The company reported in May that the SIROCCO and CALIMA trials met their primary endpoints.
The studies randomised a total of 2511 patients currently being treated with standard-of-care medicine to receive benralizumab dosed either every four weeks or every four weeks for the first three doses followed by every eight weeks, or placebo, for up to 56 weeks. AstraZeneca noted that all benralizumab doses were administered via subcutaneous injection using an accessorised pre-filled syringe.
Results demonstrated that treatment with benralizumab led to reductions in the annual rate of asthma exacerbations of up to 51 percent. Meanwhile, the therapy showed improvements in lung function, as measured by a change in FEV1 of up to 159 mL, which AstraZeneca said was seen at four weeks after the first benralizumab dose and sustained throughout the treatment period. In addition, patients who received benralizumab had improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath.
According to the drugmaker, the outcomes were demonstrated for the eight-week dosing regimen, with no additional benefit observed with four-week dosing, which it added "may support less-frequent dosing." Further, AstraZeneca indicated that a post-hoc analysis showed greater improvements in exacerbation rate reduction, FEV1 and total asthma symptom scores in patients with three or more asthma exacerbations in the previous year.
Chief medical officer Sean Bohen remarked "benralizumab has a unique way of working in patients with severe asthma with an eosinophilic phenotype." The therapy, which is in-licensed from Kyowa Hakko Kirin's BioWa unit, is an anti-eosinophil monoclonal antibody that induces direct, rapid and near-complete depletion of eosinophils, with an onset of action within 24 hours.
The company noted that data from the studies will be included in regulatory submissions for benralizumab that are planned for the US and EU later this year. Tom Keith-Roach, head of AstraZeneca's respiratory, inflammation and autoimmune business, remarked that treating uncontrolled severe asthma is a big opportunity, since this relatively small group of patients accounts for half of all asthma-related healthcare costs. "Analysts estimate the severe asthma biologics market by the early 2020s to be between $6.5 billion and $10 billion (a year), and we expect to have a competitive share of that based on this clinical profile," Keith-Roach commented.
AstraZeneca estimates that benralizumab will generate annual sales of $2 billion, although analysts forecast revenue of $485 million in 2021. For related analysis, read ViewPoints: Has AstraZeneca's benralizumab bet paid off? For more information on drugs under development for asthma, see Targeted Therapies In Asthma.
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