Amgen's Tezspire Shows Promise in Treating Eosinophilic Esophagitis
Amgen and AstraZeneca announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE in patients living with eosinophilic esophagitis (EoE). The trial 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.
The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across these endpoints at week 24, which were sustained through week 52. Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen, said 'We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition.'
EoE is a chronic and progressive disorder affecting more than 470,000 people in the U.S. The disease can lead to dysphagia, food impaction, and esophageal narrowing, making daily meals difficult and stressful for patients. Arjan Bredenoord, M.D., gastroenterologist and professor at the Amsterdam University Medical Center, said 'The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab could provide a new approach to treating EoE.'
The safety profile of TEZSPIRE was generally consistent with its approved indications. TEZSPIRE is currently approved for the treatment of severe asthma and inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.