Patients with severe uncontrolled asthma taking AstraZeneca's experimental drug benralizumab in a late-stage study either significantly reduced or stopped altogether their intake of oral corticosteroids (OCS), while the drug was also shown to dramatically cut related hospitalisations.
Severe uncontrolled asthma is potentially fatal with patients experiencing frequent exacerbations and significant limitations on lung function and quality of life. Uncontrolled asthma can lead to a dependence on OCS, with systemic steroid exposure potentially leading to serious and irreversible short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression, cardiovascular disease and immunosuppression.
According to data from the Phase III ZONDA trial, patients in the benralizumab group were more than four times as likely to reduce their OCS dose than those in the placebo arm, while the median reduction in OCS dose was found to be 75 percent versus 25 percent with placebo.
Secondary endpoints were also met, including a greater than or equal to 50 percent reduction in OCS observed in 66 percent of patients on benralizumab (eight-week dosing regimen) compared to 37 percent receiving placebo.
At the same time, analysis of prevention or reduction of acute asthma events in benralizumab treated patients on the eight-week dosing regimen showed a 70 percent cut in the overall annual exacerbation rate versus placebo, and a 93 percent reduction in exacerbations requiring emergency room visits or hospitalisations.
“Benralizumab showed an impressive clinical efficacy by reducing exacerbations rate by up to 70 percent at the same time enabling patients with severe asthma to significantly lower their prednisone dose and maintain their lung function. This is likely due to its unique mechanism of action of inhibiting the receptor for interleukin-5 and potentially depleting blood and airway eosinophils,” noted lead trial investigator Dr Parameswaran Nair, Professor of Respiratory Medicine at McMaster University in Hamilton, Canada.
The data, published in the New England Journal of Medicine, were included in regulatory filings for the drug in the US, EU, Japan and several other countries around the globe, the firm noted.
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. AZ has exclusive rights for the drug in all other countries including the US and Europe.