AstraZeneca sees positive results from asthma treatment trial
AstraZeneca, alongside its partner Amgen, announced positive results from the ‘NAVIGATOR’ phase 3 trial for the potential new medicine ‘tezepelumab’ on Tuesday, in patients with severe, uncontrolled asthma.
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The FTSE 100 pharmaceutical giant said NAVIGATOR met the primary endpoint with tezepelumab added to standard-of-care, demonstrating a “statistically significant and clinically meaningful” reduction in the annualised asthma exacerbation rate over 52 weeksin the overall patient population, compared to placebo when added to standard-of-care.
It said standard-of-care was medium- or high-dose inhaled corticosteroids, plus at least one additional controller medication with or without oral corticosteroids.
In the subgroup of patients with baseline eosinophil counts of less than 300 cells per microlitre the trial also met the primary endpoint, it said that with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in the annualised asthma exacerbation rate.
Similar reductions were observed in the subgroup of patients with baseline eosinophil counts of less than 150 cells per microlitre.
Tezepelumab was said to have been “very well tolerated” in patients with severe asthma, with preliminary analyses showing no clinically meaningful differences in safety results between the tezepelumab and placebo groups.
AstraZeneca said results from the NAVIGATOR trial would be presented at a forthcoming medical meeting.
“Tezepelumab works differently from any other asthma biologic medicine and targets multiple inflammatory pathways that contribute to asthma symptoms and exacerbations,” said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.
“Building on the broad efficacy previously seen with tezepelumab, these are exciting data that bring us one step closer to delivering a medicine to severe asthma patients, including those with low eosinophil counts.”
AstraZeneca described tezepelumab as a potential first-in-class medicine, which blocks the action of thymic stromal lymphopoietin - an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.
NAVIGATOR was the first phase 3 trial to show benefit in severe asthma by targeting thymic stromal lymphopoietin.
At 0918 GMT, shares in AstraZeneca were up 1.83% at 8,454p.