AstraZeneca’s Phase III trial shows benralizumab minimises OCS use in asthma patients

23rd May 2017 (Last Updated May 23rd, 2017 18:30)

AstraZeneca has reported positive results from its Phase III clinical trial of benralizumab in combination with standard-of-care treatment for patients with severe asthma.

AstraZeneca has reported positive results from its Phase III clinical trial of benralizumab in combination with standard-of-care treatment for patients with severe asthma.

Benralizumab is an anti-eosinophil monoclonal antibody designed to trigger direct and near-complete depletion of eosinophils through antibody-dependent, cell-mediated cytotoxicity (ADCC).

The subcutaneous 30mg of benralizumab was found to minimise the use of oral corticosteroid (OCS) in the case of dependent patients, as well as maintain the asthma control.

The randomised, double-blind, parallel-group, placebo-controlled, multicentre Phase III trial evaluated the drug over 28 weeks in 220 severe, uncontrolled asthma patients, who needed treatment with high-dose inhaled corticosteroid (ICS), a long-acting beta2 agonist (LABA) and OCS.

The trial included administration of benralizumab for every four or eight weeks.

AstraZeneca chief medical officer and global medicines development executive vice-president Sean Bohen said: “One of the known clinical characteristics of the eosinophilic asthma phenotype is an over-reliance on oral steroids to manage severe uncontrolled disease.

"One of the known clinical characteristics of the eosinophilic asthma phenotype is an over-reliance on oral steroids to manage severe uncontrolled disease."

“What is exciting about the ZONDA trial is that we have shown benralizumab delivers a clinically meaningful OCS reduction alongside a substantial reduction in asthma exacerbation rate, including emergency treatment or hospitalisations in this difficult-to-treat patient population.”

The trial met the primary endpoint of a statistically significant and clinically relevant decrease in daily maintenance OCS use and the secondary endpoints of reduction or discontinuation of OCS during the eight weeks of treatment period.

It was found that benralizumab-treated patients were more than four times as likely to minimise their OCS dose compared to placebo.

The drug was observed to be well-tolerated and the overall adverse events were consistent with previous Phase III studies.


Image: Illustration of lungs affected with asthma. Photo: courtesy of BruceBlaus.