AstraZeneca says that its investigational respiratory biologic benralizumab has turned in another successful performance in clinical trials, significantly reducing asthma exacerbations compared to a placebo.
The SIROCCO and CALIMA trials looked at the efficacy and safety of two dose regimens of the drug as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents 12 years of age and older.
The primary analysis population included patients on high-dose inhaled corticosteroids (ICS) plus long-acting β2-agonist (LABA) with a baseline blood eosinophil count ≥ 300 cells/microliter. Patients were randomised to receive benralizumab 30mg every four weeks; 30mg every four weeks for the first three doses followed by 30mg every 8 weeks; or placebo.
As well as showing efficacy in reducing exacerbations, safety and tolerability for the anti-eosinophil monoclonal antibody were generally consistent with those reported in previous trials, the firm noted.
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."
Full data will be presented at a future medical meeting, it said, also noting that regulatory submissions in the US and EU are pencilled in for the second half of this year.
In 2014 a study published in The Lancet Respiratory Medicine showed that the drug cut asthma exacerbations by approximately 40 percent-70 percent depending on the dose received and baseline blood eosinophil level. The study also met its secondary endpoints of improvements in lung function and asthma control.
However, GlaxoSmithKline's rival asthma biologic has already made it across the finish line in both Europe and the US, and Teva's IL-5 inhibitor Cinquair (reslizumab) has also bagged approval in the latter region, with both targeting eosinophilic forms of the disease.
Benralizumab 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. AstraZeneca has exclusive rights for the drug in all other countries including the US and Europe.