Biopharmaceutical companies AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) and Amgen Inc (NASDAQ:AMGN) on Thursday reported positive results from the Phase III CROSSING trial showing that Tezspire (tezepelumab) delivered statistically significant and clinically meaningful improvements in eosinophilic esophagitis (EoE) across both co-primary and all key secondary endpoints.
At week 24, Tezspire demonstrated improvements in histologic remission and the frequency and severity of dysphagia (difficulty swallowing) versus placebo, with benefits sustained through week 52 across both doses tested.
The safety profile was generally consistent with Tezspire's approved indications.
CROSSING was a randomised, double-blind trial evaluating subcutaneous Tezspire every four weeks versus placebo in adults and adolescents with symptomatic and uncontrolled EoE receiving maintenance therapy.
EoE is a chronic inflammatory disorder of the esophagus affecting more than 470,000 people in the United States, with nearly half of patients, including adolescents, failing to achieve adequate disease control with current first-line treatments.
AstraZeneca said the results support Tezspire's potential in a third epithelial-driven inflammatory disease, with full results to be presented to regulatory authorities and the scientific community at an upcoming medical meeting.
Tezspire is currently approved for severe asthma in more than 70 countries and for chronic rhinosinusitis with nasal polyps in the US, EU, China and Japan, while Phase III trials in chronic obstructive pulmonary disease remain ongoing.
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