AstraZeneca (LSE:AZN) said its Phase III CROSSING trial of Tezspire met both co-primary endpoints in patients with eosinophilic esophagitis (EoE), a chronic inflammatory disorder of the esophagus.
The drug, developed with Amgen, showed statistically significant and clinically meaningful improvements in histologic remission and dysphagia symptoms compared with placebo at week 24, sustained through week 52 across both doses tested.
EoE affects more than 470,000 people in the US, with prevalence up five-fold since 2009, and nearly half of patients fail to achieve adequate control on current first-line treatments such as dietary restriction and corticosteroids.
Tezspire is already approved for severe asthma and chronic rhinosinusitis with nasal polyps; a positive EoE readout would mark a third epithelial-driven inflammatory disease for the drug, reinforcing what AstraZeneca calls its differentiated mechanism targeting thymic stromal lymphopoietin (TSLP).
"The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating this disease", said Arjan Bredenoord, the trial's primary investigator and a gastroenterologist at Amsterdam University Medical Center.
Sharon Barr, AstraZeneca's Executive Vice President of BioPharmaceuticals R&D, said the results "reinforce our confidence" in Tezspire's mechanism.
Under the companies' collaboration, AstraZeneca leads development while Amgen leads manufacturing, sharing costs and profits equally.
Full trial results will be presented at an upcoming medical meeting and submitted to regulatory authorities.
News Intelligence what this means for the company
Tezspire met both co-primary endpoints in the Phase III CROSSING trial for eosinophilic esophagitis, showing statistically significant improvements in histologic remission and dysphagia symptoms versus placebo at week 24, sustained through week 52. This positions the drug for a third approved indication—after severe asthma and chronic rhinosinusitis with nasal polyps—and reinforces AstraZeneca's confidence in TSLP as a differentiated mechanism across epithelial-driven inflammatory diseases.
- Amgen shares manufacturing responsibility and profits equally under the collaboration; the EoE approval pathway may expand the addressable market for both partners' commercial infrastructure.
A third indication expands Tezspire's revenue potential and validates the TSLP mechanism across a growing disease area (EoE prevalence up five-fold since 2009, with nearly half of current patients failing first-line control). Regulatory submission and approval timelines remain unspecified, so near-term revenue impact is uncertain.
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