AZ, Amgen positive Ph3 results for Tezspire in EoE

AstraZeneca and Amgen have announced the first Phase III results for Tezspire (tezepelumab) in eosinophilic oesophagitis (EoE), the CROSSING trial meeting both co-primary and all key secondary endpoints in adults and adolescents with EoE.

EoE is a chronic and progressive epithelial-driven inflammatory disorder of the oesophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009. Guts Charity UK states that the estimated number of people living with EoE is 34 per 100,000 people – almost 1 in 3,000. Inflammation of the oesophagus can lead to dysphagia, food impaction, and oesophageal narrowing.

Nearly half of EoE patients, including adolescents, do not achieve adequate disease control with current first-line treatments, which include dietary restriction, swallowed topical corticosteroids, and proton pump inhibitors.

Tezspire is a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. Tezspire is currently approved for the treatment of severe asthma in the US, EU, China, Japan, and more than 70 countries worldwide.

It is also approved for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in the US, EU, China, and Japan.

The Phase III JOURNEY and EMBARK trials evaluating Tezspire in chronic obstructive pulmonary disease (COPD) are ongoing.

The CROSSING trial is a randomised, double-blind trial that evaluated the efficacy and safety ofTezspire administered subcutaneously every four weeks compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance therapy.

Tezspire demonstrated statistically significant and clinically meaningful improvements versus placebo in both histologic remission (measuring inflammation in esophageal tissue) and patient-reported dysphagia at Week 24. Improvements were sustained through Week 52, and Tezspire’s safety and tolerability were consistent with the medicine’s known clinical profile.

Arjan Bredenoord, MD, gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, the Netherlands, as well as primary investigator in the trial, stated: “The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement.”

Sharon Barr, executive VP of biopharmaceuticals R&D at AstraZeneca, commented: “Epithelial science represents an important and rapidly evolving area in respiratory and immunology medicine, and we look forward to sharing these results at an upcoming medical meeting and with regulatory authorities as quickly as possible.”

The 2012 Collaboration Agreement between Amgen and AstraZeneca has been amended and updated over time. Under the agreement, Amgen and AstraZeneca jointly commercialise Tezspire in the US.