AstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD.
Dr. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”
The pivotal Phase III trials GALATHEA and TERRANOVA are randomised, double-blinded, 56-week placebo-controlled, multi-centre trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.1
The safety and tolerability findings in GALATHEA were consistent with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting.
Fasenra is AstraZeneca’s first respiratory biologic and is currently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.
The results of the GALATHEA trial do not impact the approved indication in severe eosinophilic asthma.