View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
May 14, 2018

AstraZeneca reveals negative findings from GALATHEA trial

AstraZeneca has reported negative results from the GALATHEA trial after the study failed to meet its primary endpoint.

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).

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.

“We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”

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.

AstraZeneca 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.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU