AstraZeneca has reported negative results from the GALATHEA trial after the study failed to meet its primary endpoint.
However, the safety and tolerability data reported in GALATHEA were consistent with those observed in previous trials of Fasenra (benralizumab).
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GALATHEA was a Phase III trial designed to evaluate the safety and efficacy of Fasenra to treat patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The randomised, double-blind, 56-week placebo-controlled, multi-centre trial enrolled 1,656 COPD patients with a history of exacerbations.
The trial’s primary endpoint was a statistically significant reduction of exacerbations in COPD patients.
Its secondary endpoints included evaluation of the effect of Fasenra on health status/health-related quality of life, analyse the effect of benralizumab on pulmonary function, among others.
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By GlobalDataAstraZeneca global medicines development executive vice-president and chief medical officer Dr Sean Bohen 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.”
Fasenra is a monoclonal antibody that employs natural killer cells to induce rapid and near-complete depletion of eosinophils, a type of white blood cell that is a normal part of the body’s immune system. The drug has been developed by AstraZeneca’s biologics research and development arm, MedImmune.
Fasenra is currently approved as an add-on treatment for severe eosinophilic asthma in the US, the EU, Japan, and other countries.
