WILMINGTON, Del. — AstraZeneca and Amgen announced positive results from the Phase III CROSSING trial, showing that TEZSPIRE (tezepelumab) significantly improved swallowing symptoms and achieved histologic and endoscopic remission in adolescents and adults with eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.
The findings, presented at United European Gastroenterology Week 2026 in Barcelona, Spain, demonstrated statistically significant improvements in patients receiving TEZSPIRE compared with placebo, with benefits sustained through 52 weeks.
At week 24, 64.8% of patients receiving the 210 mg dose and 68.9% receiving the 420 mg dose achieved histologic remission, compared with 3.5% of patients receiving placebo.
TEZSPIRE also significantly reduced the frequency and severity of difficulty swallowing, known as dysphagia. Patients receiving the 210 mg and 420 mg doses experienced improvements of 18.8 and 22 points, respectively, on the Dysphagia Symptom Questionnaire, compared with 14.7 points for placebo.
The benefits continued through week 52, when histologic remission rates reached 67.8% for the 210 mg group and 63.3% for the 420 mg group, compared with 5.4% for placebo.
The treatment also improved endoscopic measures of inflammation and tissue damage. At week 52, 34.4% of patients receiving 210 mg and 29.5% receiving 420 mg achieved total endoscopic remission, compared with 4.1% of placebo recipients.
Eosinophilic esophagitis causes inflammation of the esophagus that can lead to difficulty swallowing, food becoming stuck and narrowing of the esophagus. Nearly half of patients, including adolescents, do not achieve adequate disease control with existing treatments, which include dietary restrictions, topical corticosteroids and proton pump inhibitors.
“The prevalence of eosinophilic esophagitis is on the rise and has become one of the fastest-growing chronic gastrointestinal conditions we see in the clinic,” said Evan Dellon, MD, professor of medicine at the University of North Carolina School of Medicine and U.S. primary investigator in the CROSSING trial.
“The CROSSING data suggest that tezepelumab, dosed once every four weeks, would be an important new treatment option that addresses key treatment goals in EoE across symptomatic, histologic and endoscopic outcomes,” Dellon added.
Arjan Bredenoord, MD, gastroenterologist and professor at Amsterdam University Medical Center and international coordinating investigator for the trial, said the results demonstrated sustained improvements across multiple measures of the disease.
“The CROSSING trial results are compelling because they show consistent, lasting improvements across three key measures of eosinophilic esophagitis — histologic remission, frequency and severity of dysphagia and endoscopic remission — sustained through 52 weeks,” Bredenoord said.
Patients in the trial were permitted to continue taking stable background medications, including proton pump inhibitors and swallowed topical corticosteroids.
TEZSPIRE demonstrated a safety profile consistent with its existing approved uses. The most frequently reported adverse events were upper respiratory infections, headaches and diarrhea.
Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said the findings support the drug’s potential to treat a broader range of inflammatory diseases.
“The exciting results from the CROSSING trial further support the broad potential of TEZSPIRE and its unique mode of action targeting TSLP at the top of the inflammatory cascade,” Barr said.
AstraZeneca plans to share the CROSSING trial findings with regulatory authorities as it seeks to expand the treatment’s use to patients with eosinophilic esophagitis.
TEZSPIRE is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), a protein involved in inflammatory responses. The drug is currently approved for severe asthma in more than 70 countries and for chronic rhinosinusitis with nasal polyps in several major markets, including the United States, European Union, China and Japan.
The companies are also evaluating TEZSPIRE in ongoing Phase III trials for chronic obstructive pulmonary disease.
