AstraZeneca announced that two Phase III trials have shown that the company’s drug benralizumab can cut down the production of eosinophil cells and improve the lung function in patients suffering from severe asthma.
Benralizumab is an IL-5 monoclonal antibody that attaches itself to the eosinophil cells and blocks it from binding to the receptors. An overproduction of eosinophil causes airway inflammation and airway hyper-responsiveness in approximately 50 per cent of asthma patients and can lead to increased asthma symptoms, impaired lung function, and frequent exacerbations.
The results of the benralizumab trials have demonstrated efficacy across the full range of baseline blood eosinophil counts and have been predicted to have a greater response in patients who have a combination of higher baseline blood eosinophil and a history of more frequent exacerbations. In phase I/II trials it demonstrated a rapid and direct depletion of circulating eosinophils.
There were six trials in Phase III, but in the pivotal trials, SIROCCO and CALIMA, there were dramatic reductions in exacerbations and improved lung functioning in severe, uncontrolled eosinophilic asthma patients.
“As a treating physician, I want to be confident that I am prescribing the right treatment that will provide maximum benefit to patients with severe, uncontrolled asthma,” said Dr. J. Mark FitzGerald, director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute and principal investigator of the study. “This important analysis shows benralizumab provides enhanced benefits for patients who experience more frequent exacerbations despite being on standard-of-care medicines and/or who present from higher baseline blood eosinophil counts.”
He said the data will help them identify which patients can benefit most from benralizumab. This will enable them to improve the therapeutic management of severe, uncontrolled asthma.
This possible new treatment opens up a new option for those who rely on chronic oral corticosteroids (OCS). Severe, uncontrolled asthma can lead to a dependence on OCS, which can potentially expose the user to some serious short and long-term adverse effects, including glaucoma, weight gain, diabetes, anxiety, depression, osteoporosis, cardiovascular disease, and immunosuppression.
Asthma affects over 315 million individuals worldwide, including an estimated 3 million Canadians’. These numbers are expected to rise by 2020. Currently, up to 10 per cent of asthma patients are considered severe, some of which may be uncontrolled. Severe, uncontrolled asthma is potentially fatal and has eight times higher risk of mortality than those with acute asthma.
“Severe, uncontrolled asthma affects millions of people around the world and exacerbations can be life-threatening,” Colin Reisner, head of respiratory, global medicines development at AstraZeneca, said. “The new analysis of SIROCCO and CALIMA builds on robust clinical evidence supporting benralizumab for patients with severe, uncontrolled asthma, including more recent data from the Phase III ZONDA trial.”
Benralizumab is under regulatory review in the US, Canada, EU and Japan and several other countries, with a US PDUFA date during the fourth quarter of 2017 and expected regulatory decisions elsewhere during the H1 2018.