Wilmington, Del. — AstraZeneca and Amgen said their drug TEZSPIRE (tezepelumab-ekko) delivered positive Phase III results in patients with eosinophilic esophagitis, or EoE, meeting both co-primary and all key secondary endpoints in the CROSSING trial.
The companies said TEZSPIRE produced statistically significant and clinically meaningful improvements at week 24, with benefits maintained through week 52 across both doses tested.
The trial’s co-primary endpoints were histologic remission and improvement in the frequency and severity of dysphagia, or difficulty swallowing, compared with placebo. The drug’s safety profile was generally consistent with its currently approved uses.
CROSSING is a randomized, double-blind study evaluating TEZSPIRE administered by subcutaneous injection every four weeks versus placebo in adults and adolescents with symptomatic, uncontrolled EoE who were receiving maintenance therapy.
Histologic remission was measured by reductions in peak eosinophil counts in esophageal tissue, while dysphagia was assessed using the patient-reported Dysphagia Symptom Questionnaire.
EoE is a chronic inflammatory disease of the esophagus that affects more than 470,000 people in the United States, according to the companies. The condition can cause difficulty swallowing, food impaction and narrowing of the esophagus.
“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,” said Arjan Bredenoord, M.D., Gastroenterologist and Professor at Amsterdam University Medical Center and primary investigator in the trial.
“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,” Bredenoord said.
Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said the results expand evidence for TEZSPIRE across epithelial-driven inflammatory diseases.
“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,” Barr said.
The companies plan to present full results at an upcoming medical meeting and submit the findings to regulatory authorities.
TEZSPIRE is a human monoclonal antibody that blocks thymic stromal lymphopoietin, or TSLP, a cytokine involved in multiple inflammatory pathways. It is already approved for severe asthma in more than 70 countries and for chronic rhinosinusitis with nasal polyps in several major markets.
The drug is also being evaluated in the Phase III JOURNEY and EMBARK trials for chronic obstructive pulmonary disease.
