(EGPA), based on data from 140 individuals.
The unpublished topline results of the phase 3 MANDARA study were shared in a press release from benralizumab’s manufacturer, AstraZeneca. More detailed findings are scheduled to be presented at a future medical meeting, according to the company.
EGPA, although rare, can damage multiple organs including the heart, lungs, gastrointestinal tract, skin, and nerves, and can be fatal if left untreated, but treatment options are limited, and mepolizumab, an anti-interleukin (IL)-5 monoclonal antibody, is the only currently approved treatment.
In the study, adults with EGPA were randomized to a single 30-mg subcutaneous injection of benralizumab or three separate 100-mg subcutaneous injections of mepolizumab once every 4 weeks. The primary endpoint was remission rates after 36 and 48 weeks of treatment. Remission was defined as a Birmingham Vasculitis Activity Score of 0 and use of 4 mg/day or less of oral corticosteroids.
At 36 weeks and 48 weeks, remission rates for benralizumab were noninferior to mepolizumab. According to Clinicaltrials.gov, the study is scheduled to last for 52 weeks to compare the remission rates with the two treatments, and collect data from an extension that allows each patient at least 1 year of treatment in an open-label format.
Benralizumab, also a monoclonal antibody, differs in action from mepolizumab by binding directly to the IL-5 receptor alpha on eosinophils.
“This trial demonstrates that a biologic medicine given in a single monthly injection could help patients achieve remission rates comparable to the current standard of care, adding to the importance of benralizumab as a potential treatment option for eosinophilic granulomatosis with polyangiitis,” Michael Wechsler, MD, principal investigator on the MANDARA study, said in the press release.
The safety and tolerability of benralizumab in the MANDARA study were consistent with drug’s known profile, according to the company.
Benralizumab is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, the European Union, and Japan, among other countries, and for self-administration in the United States, the European Union, and other countries, according to the company.
Benralizumab also is in development for other eosinophilic diseases, including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome, and received an Orphan Drug Designation from the U.S. Food and Drug Administration in 2018, according to the company.