AstraZeneca and Amgen’s Tezspire (tezepelumab) has delivered positive high-level results in the Phase III CROSSING trial, showing statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints in EoE patients.

 

The results at week 24 were sustained through week 52 across both doses tested, strengthening the case for Tezspire as a potential new treatment option for patients with the chronic inflammatory disease.

 

The trial’s two co-primary endpoints assessed histologic remission and the frequency and severity of dysphagia, or difficulty swallowing, compared with placebo. Tezspire’s safety profile was generally consistent with its established approved indications.

 

CROSSING was a randomised, double-blind Phase III trial evaluating subcutaneous Tezspire administered every four weeks versus placebo in adults and adolescents with symptomatic, uncontrolled EoE despite maintenance therapy.

 

Histologic remission was defined by a low count of peak eosinophils in esophageal tissue, while changes in the frequency and severity of dysphagia were measured using the patient-reported Dysphagia Symptom Questionnaire (DSQ).

 

EoE is a chronic, progressive inflammatory disorder of the esophagus that affects more than 470,000 people in the US. Its prevalence has increased five-fold since 2009. The disease can cause dysphagia, food impaction and narrowing of the esophagus, while nearly half of patients, including adolescents, fail to achieve adequate control with current first-line treatments such as dietary restrictions, swallowed topical corticosteroids and proton pump inhibitors.

 

For patients, the possibility of food moving slowly or becoming lodged in the esophagus can turn everyday meals into a difficult and stressful experience.

 

Arjan Bredenoord, Gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, The Netherlands, and primary investigator in the trial, said: “Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food, and emotional and daily-life impacts of the disease. 

 

"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 this disease, with the potential to help more patients achieve remission and symptom improvement.”

 

The findings also add to evidence supporting Tezspire’s broader role in epithelial-driven inflammatory diseases.

 

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D said: “The positive results of the Phase III CROSSING trial reinforce our confidence in the differentiated mechanism of action of Tezspire, which has now demonstrated clinically meaningful efficacy in a third epithelial-driven inflammatory disease. 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.”

 

AstraZeneca and Amgen said full CROSSING results will be submitted to regulatory authorities and presented to the scientific community at an upcoming medical meeting.

 

Tezspire is a first-in-class human monoclonal antibody that blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine positioned at the top of multiple inflammatory pathways.