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.”