Tezspire shows significant histologic remission and symptom improvement in Phase III eosinophilic esophagitis trial
AstraZeneca and Amgen announced that TEZSPIRE (tezepelumab) met both co‑primary endpoints in the Phase III CROSSING trial for eosinophilic esophagitis. At week 24, histologic remission was achieved in 64.8% of patients receiving 210 mg and 68.9% receiving 420 mg, versus 3.5% on placebo. The benefits were sustained through week 52, with remission rates of 67.8% and 63.3% respectively, and continued reductions in dysphagia scores. The companies said they will submit the data to regulatory authorities for a new indication.
Why it matters
The company expects the data to support regulatory submissions for a new EoE indication, which could add a sizable revenue stream to both firms. The trial’s positive outcome may also lift investor sentiment, as reflected in modest share price gains reported after the announcement.
Key facts
- 1Histologic remission at week 24 was 64.8% for the 210 mg dose and 68.9% for the 420 mg dose, compared with 3.5% on placebo (p<0.001). amgen.com
- 2At week 52, histologic remission was 67.8% (210 mg) and 63.3% (420 mg) versus 5.4% on placebo (both p<0.001). amgen.com
- 3Dysphagia symptom scores improved by 22.1 points (210 mg) and 24.0 points (420 mg) versus 13.2 points for placebo at week 52 (both p<0.001). amgen.com
- 4Total endoscopic remission at week 52 was achieved by 34.4% (210 mg) and 29.5% (420 mg) versus 4.1% on placebo (p<0.001). amgen.com
- 5The results will be presented in a late‑breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain. amgen.com
- 6Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said the data will be shared with regulatory authorities to bring TEZSPIRE to EoE patients as quickly as possible. stocktitan.net
Summary written by AlphAI AI Desk from 15 of 15 sources. Not investment advice. Figures are as stated by the linked sources.