The trialâ€™s primary endpoint was a statistically significant reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca’s benralizumab (Fasenra) did not demonstrate a statistically significant reduction in exacerbations of patients with chronic obstructive pulmonary disease (COPD) in phase 3 trial results, the company announced in a press release.
The results are based off the GALATHEA phase 3 clinical trial assessing the safety and efficacy of benralizumab as an add-on to dual or triple inhaled therapy compared with placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.
According to the press release, approximately 30% to 40% of moderate to severe COPD patients on triple negative inhaled therapy remain uncontrolled and continue to experience exacerbations, indicating an unmet need for treatments designed for these patients.
Benralizumab is a monoclonal antibody that recruits natural killer cells to induce rapid and near-compete depletion of eosinophils within 24 hours, as confirmed in phase 1 and phase 2 severe asthma trials, according to AstraZeneca. Benralizumab is AstraZeneca’s first respiratory biologic now approved in severe eosinophilic asthma.
The trial did not meet its primary endpoint of statistically significant reduced exacerbations, but the safety and tolerability findings in GALATHEA were consistent with those observed in previous trials with benralizumab.
AstraZeneca’s second phase 3 trial TERRANOVA is still ongoing, with results expected later this quarter.
“COPD is a debilitating disease with a significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies,” Dr Sean Bohen, executive vice president of Global Medicines Development and chief medical officer, said in the press release. “We will not await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”
According to the press release, the trial’s findings do not affect the approved indication in severe eosinophilic asthma.
AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease [news release]. AstraZeneca’s website. https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-provides-update-on-galathea-phase-iii-trial-for-fasenra-in-chronic-obstructive-pulmonary-disease-11052018.html