AstraZeneca (AZN) Announces SIROCCO, CALIMA Trials Met Primary, Key Secondary Endpoints

September 6, 2016 7:48 AM EDT

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Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.

The SIROCCO and CALIMA trials evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens as add-on therapy to standard-of-care medicine across primary and key secondary endpoints. Results showed:

  • Reductions in the annual rate of asthma exacerbations (up to 51%)
  • Improvement in lung function (change in FEV1 of up to 159 mL), which was seen at 4 weeks after the first benralizumab dose and sustained throughout the treatment period
  • Improvement in asthma symptoms, such as wheeze, cough, chest tightness and shortness of breath

The outcomes were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. In addition, post-hoc analysis showed greater improvements in exacerbation rate reduction, FEV1 and total asthma symptom scores in patients with a history of more frequent asthma exacerbations (≥ 3 in the previous year). Detailed results were published today in The Lancet for the Phase III SIROCCO and CALIMA trials.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “Severe asthma affects the lives of millions of patients around the world and can be life threatening. The SIROCCO and CALIMA Phase III trials have shown that benralizumab can offer a meaningful treatment option for patients as evidenced by reductions in exacerbations, improvement in lung function and symptoms, with the promise of fewer doses a year. Benralizumab has a unique way of working in patients with severe asthma with an eosinophilic phenotype and reflects AstraZeneca’s progress in bringing the next generation of respiratory medicines to patients.”

The adverse event frequency was similar between benralizumab-treated patients versus placebo-treated patients for both SIROCCO and CALIMA (72% and 74% for all benralizumab treated patients vs. 76% and 78% for placebo-treated patients observed in SIROCCO and CALIMA, respectively). The most common (≥5%) adverse events in benralizumab-treated patients observed in SIROCCO were asthma, nasopharyngitis, upper respiratory infection, headache, bronchitis, sinusitis, influenza and pharyngitis; and in CALIMA were nasopharyngitis, asthma, bronchitis, upper respiratory tract infection, headache and sinusitis.

Severe uncontrolled asthma is a debilitating and potentially fatal form of the disease, where patients experience frequent exacerbations every year and have significant limitations on lung function and quality of life. Uncontrolled asthma can lead to a dependence on oral corticosteroids (OCS), with systemic steroid exposure leading to serious and irreversible adverse effects.

Benralizumab is an anti-eosinophil monoclonal antibody that induces direct, rapid and near-complete depletion of eosinophils, with an onset of action within 24 hours as confirmed in early phase I/II trials. Eosinophils are the biological effector cells that drive inflammation and airway hyper-responsiveness in approximately 50% of asthma patients, leading to frequent exacerbations, impaired lung function and asthma symptoms.

The data from the SIROCCO and CALIMA trials will be included in regulatory submissions for benralizumab that are planned for the US and EU later in 2016.



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