AstraZeneca's Tezspire meets endpoints in esophagitis trial

AstraZeneca (NASDAQ: AZN) and Amgen reported positive high-level results from the Phase III CROSSING trial evaluating Tezspire (tezepelumab) in patients with eosinophilic esophagitis (EoE), a chronic inflammatory disorder of the esophagus.

The trial met both co-primary endpoints at week 24: histologic remission, defined as a low count of peak eosinophils in esophageal tissue, and a reduction in the frequency and severity of dysphagia, measured by the patient-reported Dysphagia Symptom Questionnaire. Results were sustained through week 52 in both doses tested. The safety profile was described as generally consistent with Tezspire's approved indications.

CROSSING was a randomized, double-blind trial evaluating Tezspire administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy.

EoE affects more than 470,000 people in the U.S., with prevalence increasing five-fold since 2009, according to the press release. The condition can cause dysphagia, food impaction, and esophageal narrowing. Nearly half of patients do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids, and proton pump inhibitors.

Tezspire is currently approved for severe asthma in the U.S., EU, China, Japan, and more than 70 countries, and for chronic rhinosinusitis with nasal polyps in the U.S., EU, China, and Japan. The companies said full results will be shared with regulatory authorities and presented at an upcoming medical meeting.

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