AstraZeneca and Amgen’s Tezspire has met both co-primary and key secondary endpoints in a Phase 3 trial in eosinophilic esophagitis.

Tezspire improves disease and swallowing symptoms

Results from the Phase 3 CROSSING trial showed that Tezspire (tezepelumab) produced statistically significant and clinically meaningful improvements in adults and adolescents with symptomatic, uncontrolled eosinophilic esophagitis (EoE).

The improvements were reported across both co-primary endpoints at week 24 and were sustained through week 52 at both doses tested.

The co-primary endpoints assessed histologic remission and the frequency and severity of dysphagia, or difficulty swallowing, compared with placebo.

Histologic remission was assessed by measuring eosinophil levels in oesophageal tissue, while changes in dysphagia were measured using the patient-reported Dysphagia Symptom Questionnaire.

The trial was a randomised, double-blind study comparing Tezspire administered subcutaneously every four weeks with placebo in patients receiving maintenance therapy.

Arjan Bredenoord, gastroenterologist and professor at Amsterdam University Medical Center 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.”

Bredenoord added that the results sustained over 52 weeks could provide a new treatment approach for patients with the condition.

Eosinophilic esophagitis can affect eating

EoE is a chronic inflammatory disorder affecting the oesophagus. The condition can cause difficulty swallowing, food impaction and narrowing of the oesophagus.

More than 470,000 people in the US are affected by EoE, according to AstraZeneca and Amgen, with prevalence reported to have increased five-fold since 2009.

Current first-line treatment options include dietary restrictions, swallowed topical corticosteroids and proton pump inhibitors. The companies said a substantial proportion of patients do not achieve adequate disease control with these approaches.

The CROSSING results therefore add to evidence supporting the investigation of Tezspire in EoE, although the companies have not yet released the numerical results from the trial.

Full results are due to be presented at an upcoming medical meeting and submitted to regulatory authorities.

Tezspire being investigated across inflammatory diseases

Tezspire is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine involved in multiple inflammatory pathways.

The treatment is already approved for severe asthma in the US, EU, China, Japan and other countries, and for chronic rhinosinusitis with nasal polyps in several markets.

Sharon Barr, executive vice president, BioPharmaceuticals R&D, said: “The positive results of the Phase 3 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.”

AstraZeneca and Amgen are also evaluating Tezspire in chronic obstructive pulmonary disease through the ongoing Phase 3 JOURNEY and EMBARK trials.

The companies said the CROSSING results would be shared with regulatory authorities and the scientific community at an upcoming medical meeting.