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AstraZeneca’s COPD drug Fasenra fails to meet primary endpoint in phase III trial

PBR Staff Writer Published 14 May 2018

AstraZeneca’s respiratory drug Fasenra (benralizumab) has failed to meet its primary endpoint in the Galathea phase III trial.

The study has failed to achieve statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

AstraZeneca is continuing the Terranova trial, which is also a second phase III trial of Fasenra. The results from the trial are expected to be revealed by the end of this quarter.

AstraZeneca chief medical officer and global medicines development executive vice president 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.”

Galathea and Terranova are randomised, double-blinded, 56-week placebo-controlled and multi-centre trials designed to evaluate the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared against placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.

The safety and tolerability findings in Galathea study are in line with the earlier trials carried out with Fasenra.

AstraZeneca said the full assessment of the data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting.

Fasenra is said to be the firm’s first respiratory biologic, and is presently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.

Fasenra is a monoclonal antibody that enrolls natural killer cells to stimulate rapid and near-complete depletion of eosinophils.

AstraZeneca, along with its global biologics research and development arm MedImmune, developed Fasenra. It is in-licensed from Japan-based Kyowa Hakko Kirin’s wholly-owned subsidiary BioWa.

Voyager is AstraZeneca’s Phase III Fasenra clinical trial program in COPD, which recruited around 4,000 patients. Galathea and Terranova trials are part of Voyager program.