Tezspire hits key endpoints in Phase III eosinophilic esophagitis trial

AstraZeneca and Amgen's TEZSPIRE (tezepelumab) met co-primary endpoints in the Phase III CROSSING trial for eosinophilic esophagitis (EoE), achieving statistically significant histologic remission and reductions in swallowing difficulty at week 24 compared to placebo, according to results presented at United European Gastroenterology Week 2026 in Barcelona, Spain.

In the randomized, double-blind, placebo-controlled trial of 368 patients aged 12 to 80, TEZSPIRE administered subcutaneously every four weeks achieved histologic remission in 64.8% of patients on the 210mg dose and 68.9% on the 420mg dose at week 24, compared to 3.5% on placebo (p<0.001). The drug also reduced dysphagia symptom scores by 18.8 points (210mg; p=0.049) and 22.0 points (420mg; p<0.001) from baseline, versus 14.7 points on placebo, as measured by the Dysphagia Symptom Questionnaire.

These results were sustained through week 52, with histologic remission rates of 67.8% (210mg) and 63.3% (420mg) versus 5.4% on placebo (p<0.001). At week 52, 34.4% and 29.5% of patients in the respective dose groups achieved total endoscopic remission, compared to 4.1% on placebo (p<0.001).

The safety profile was consistent with TEZSPIRE's approved indications. The most frequently reported adverse events were upper respiratory infection, headache and diarrhea.

TEZSPIRE is currently approved for severe asthma and chronic rhinosinusitis with nasal polyps in the US, EU, China and Japan. It holds FDA Orphan Drug Designation for EoE, granted in October 2021. AstraZeneca (LSE/STO/NYSE: AZN) stated it plans to submit the CROSSING data to regulatory authorities. Amgen co-develops the drug under a collaboration agreement in which costs and profits are shared equally.

EoE affects more than 470,000 people in the US, with prevalence increasing fivefold since 2009, according to figures cited in the press release.

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