Amgen and AstraZeneca's Tezspire Shows Promising Results in Eosinophilic Esophagitis Trial

Amgen and AstraZeneca have announced positive results from their Phase 3 CROSSING trial of Tezspire in patients living with eosinophilic esophagitis. The treatment demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24, which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia. The safety profile of Tezspire was generally consistent with its approved indications.

The CROSSING trial is a randomized, double-blind study that evaluated the efficacy and safety of Tezspire at one of two doses administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue.

The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire and measured as a mean change from baseline in DSQ score. Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.