View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
November 11, 2020

AstraZeneca and Amgen report positive results from NAVIGATOR trial

AstraZeneca and Amgen have reported positive results from the NAVIGATOR Phase III trial for Tezepelumab, a potential drug in treating patients suffering with severe, uncontrolled asthma.

AstraZeneca and Amgen have reported positive results from the NAVIGATOR Phase III trial for Tezepelumab, a potential drug in treating patients suffering with severe, uncontrolled asthma.

NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled study on adults from the age of 18 to 80 and adolescents from the age of 12 to 17 who suffer from severe, uncontrolled asthma.

Tezepelumab is being developed by AstraZeneca through a collaboration with Amgen.

Tezepelumab is claimed to block the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that is seen to have a role across a range of asthma inflammation.

NAVIGATOR achieved the primary endpoint with tezepelumab added to standard of care (SoC). It showed a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks in the total patient population, as against placebo when added to SoC.

SoC is defined as medium or high-dose inhaled corticosteroids (ICS) in addition to at least one additional controller medication with or even without oral corticosteroids (OCS).

It was found that in a subgroup of patients with baseline eosinophil counts of less than 300 cells per microlitre, the trial met the primary endpoint, with tezepelumab showing a reduction in AAER.

A similar kind of reductions in AAER were also found in the subgroup of patients with baseline eosinophil counts of less than 150 cells per microlitre.

The drug candidate was found to be well tolerated in patients suffering with severe asthma.

Preliminary analyses indicate that there were no clinically meaningful differences in safety results between the tezepelumab and placebo groups.

Severe asthma affects around 34 million people across the world.

NAVIGATOR Phase III trial principal investigator and London’s Royal Brompton Hospital’s Lung Division director and professor Andrew Menzies-Gow said: “Due to the complex nature of severe asthma, many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics.

“Today’s ground-breaking results show that tezepelumab has the potential to transform care for a broad population of severe asthma patients who are underserved today, including those without an eosinophilic phenotype.”

Related Companies

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

Thank you for subscribing to Clinical Trials Arena