27th Aug 2026 08:35
(Alliance News) - AstraZeneca PLC and Amgen Inc on Thursday announced positive top-line results from the phase 3 Crossing trial of tezepelumab in patients living with eosinophilic esophagitis.
Cambridge, England-based pharmaceuticals company AstraZeneca is in a collaboration with Thousand Oaks, California-based peer Amgen for the development and commercialisation of tezepelumab, sold under the brand name, Tezspire.
Under the collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.
On Thursday, the companies said tezepelumab showed "statistically significant and clinically meaningful" improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested.
The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing) compared to placebo. The safety profile of tezepelumab in the trial was generally consistent with its approved indications.
Jay Bradner, executive vice president of Research and Development, Artificial Intelligence and Data at Amgen said: "Tezspire improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in Tezspire as a potential new treatment for people struggling with EoE."
Eosinophilic esophagitis is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009.
Sharon Barr, executive vice president, BioPharmaceuticals R&D at AstraZeneca said the positive trial results "reinforce our confidence in the differentiated mechanism of action of Tezspire, which has now demonstrated clinically meaningful efficacy in a third epithelial-driven inflammatory disease."
Tezspire is indicated for the add-on maintenance treatment of adult and children aged 12 years and older with severe asthma, and the add-on maintenance treatment of adult and children aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps.
It is currently approved for the treatment of severe asthma in the US, EU, China, Japan and more than 70 countries across the globe, and for the treatment of inadequately controlled CRSwNP in the US, EU, China and Japan.
Full results from the trial will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.
Shares in AstraZeneca were down 0.5% at 12,168.32 pence each in London on Thursday morning, while Amgen closed down 0.4% at USD440.34 in New York on Wednesday.
By Jeremy Cutler, Alliance News reporter
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