Findings of the trials called SIROCCO and CALIMA, revealed that the monoclonal antibody compound was well tolerated and demonstrated significant reductions in the annual asthma exacerbation rate compared to placebo. The positive results will be presented at a future medical conference.
According to the Centers for Disease Control and Prevention (CDC), approximately 25 million people in the U.S. have asthma, and the incidence of the condition increases year after year. Severe asthma is often dependent on oral corticosteroid (OCS) therapy but frequent exposure to the therapy has several serious side-effects that can include osteoporosis, anxiety, depression, weight gain, glaucoma and diabetes. Uncontrolled severe cases are characterized by a mortality rate eight times higher than severe asthma.
Benralizumab, developed by MedImmune, AstraZeneca’s global biologics research and development arm, is an anti-eosinophil monoclonal antibody. Eosinophils are immune cells responsible for inflammation and airways hyper-responsiveness in approximately 50% of asthma patients. Such effects result in frequent exacerbations, impaired lung function, and reduced quality of life.
Benralizumab has been shown to induce complete depletion of eosinophils in the bone marrow, blood, and target tissue via antibody-dependent cell-mediated cytotoxicity (ADCC) – the process by which natural killer cells are activated to target the pro-inflammatory cells.
The SIROCCO and CALIMA clinical trials, part of the comprehensive WINDWARD program in asthma, evaluated the efficacy and safety of two dose regimens of benralizumab as an add-on therapy for severe uncontrolled asthma with eosinophilic inflammation in adults and adolescents aged 12 and older.
The primary populations in the trials were patients on high-dose inhaled corticosteroids (ICS) plus long-acting β2-agonist (LABA), with a baseline blood eosinophil count ≥ 300 cells/microliter. The patients were randomized to receive either benralizumab 30mg every 4 weeks, 30mg every 4 weeks for the first three doses followed by 30mg every 8 weeks, or placebo.
“Severe asthma affects the health and quality of life of millions of people around the world, and exacerbations can be life threatening for these patients. We are pleased with the top-line results from these pivotal trials as they demonstrate the potential for benralizumab to improve outcomes for patients with severe asthma,” said Sean Bohen, chief medical officer and executive vice president of Global Medicines Development, in a press release. “Benralizumab is AstraZeneca’s first respiratory biologic and its development underscores our commitment to transform the treatment of asthma and chronic respiratory disease with our next generation of respiratory medicines,”
Benralizumab is also being evaluated in patients with severe chronic obstructive pulmonary disease (COPD), in the Phase 3 VOYAGER program.