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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”