AstraZeneca and its research and development arm MedImmune have reported negative top-line results from the TERRANOVA trial after it failed to meet its primary objective.
However, the safety and tolerability results were similar to those observed in previous trials of Fasenra.
TERRANOVA is AstraZeneca’s second of the two pivotal Phase III trials designed to evaluate Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The randomised, double-blinded, 56-week placebo-controlled, multicentre trial’s primary objective included a statistically significant reduction of exacerbations in COPD patients.
The trial evaluated the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy against placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.
Findings of the TERRANOVA trial follow negative results from the company’s first pivotal Phase III trial of Fasenra for COPD, GALATHEA. The results were reported earlier this month.
AstraZeneca Global Medicines Development executive vice-president and chief medical officer Dr Sean Bohen said: “These results are disappointing because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options.
“We will now analyse the complete data sets from the GALATHEA and TERRANOVA trials to further understand these results.”
The company currently has no plan to submit a regulatory application for Fasenra, which is a monoclonal antibody that hires 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.