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Tezepelumab Phase III trial met primary endpoint
Tezepelumab Phase III trial met primary endpoint.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8031E\n AstraZeneca PLC\n 10 November 2020\n \n \n \n \n This announcement contains inside information\n \n \n \n \n \n 10 November 2020 07:00 GMT\n \n \n \n \n \n Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma\n \n \n \n \n \n Trial also met the primary endpoint in patients with low levels of eosinophils\n \n \n \n \n \n AstraZeneca and Amgen today announced positive results from the \n NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma.\n \n \n \n \n \n NAVIGATOR met the primary endpoint with \n tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful1reduction in the annualised asthma exacerbation rate (AAER) over 52weeksin the overall patient population, compared to placebo when added to SoC. SoC was medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).\n \n \n \n \n \n In the subgroup of patients with baseline eosinophil counts less than 300 cells per microlitre the trial also met the primary endpoint, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microlitre.\n \n \n \n \n \n Tezepelumab was very well tolerated in patients with severe asthma. Preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups. Results from the NAVIGATOR trial will be presented at a forthcoming medical meeting.\n \n \n \n \n \n Severe asthma is a debilitating condition affecting approximately 34 million people worldwide.2.3 Many severe asthma patients continue to experience symptoms and frequent exacerbations despite the use of high-dose asthma controller medicines, currently available biologic therapies and OCS.3-5\n \n \n \n \n \n Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR...