WILMINGTON, DE — AstraZeneca and Amgen’s TEZSPIRE met both primary endpoints in a Phase III trial of patients with eosinophilic esophagitis, extending the drug’s efficacy into a third inflammatory disease and providing results the companies plan to submit to regulators.
The CROSSING trial found statistically significant and clinically meaningful improvements in histologic remission and the frequency and severity of dysphagia, or difficulty swallowing, at 24 weeks compared with placebo, AstraZeneca reported. The improvements were maintained through 52 weeks at both doses tested.
TEZSPIRE, or tezepelumab-ekko, also met all key secondary endpoints at week 24, with those results sustained through week 52. AstraZeneca described the drug’s safety profile in the study as generally consistent with its approved indications.
The randomized, double-blind trial evaluated TEZSPIRE administered subcutaneously every four weeks against placebo in adults and adolescents with symptomatic, uncontrolled eosinophilic esophagitis, or EoE, who remained on maintenance therapy.
The first co-primary endpoint measured histologic remission based on peak eosinophil counts in esophageal tissue. The second assessed changes in the frequency and severity of swallowing difficulties using the patient-reported Dysphagia Symptom Questionnaire.
Full data weren’t included in the high-level results. AstraZeneca plans to present the findings at an upcoming medical meeting and provide them to regulatory authorities.
“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,” said Arjan Bredenoord, a gastroenterologist and professor at Amsterdam University Medical Center who served as the trial’s primary investigator.
EoE is a chronic inflammatory disorder of the esophagus that affects more than 470,000 people in the US, according to AstraZeneca. Its prevalence has increased fivefold since 2009.
Inflammation associated with the disease can cause difficulty swallowing, food impaction and narrowing of the esophagus. Nearly half of patients, including adolescents, don’t achieve adequate disease control with first-line treatments such as dietary restriction, swallowed topical corticosteroids and proton pump inhibitors, according to the company.
The CROSSING results broaden the clinical evidence for TEZSPIRE beyond its existing indications. The monoclonal antibody inhibits thymic stromal lymphopoietin, or TSLP, an epithelial cytokine involved in multiple inflammatory pathways.
“The positive results of the Phase III CROSSING trial reinforce our confidence in the differentiated mechanism of action of TEZSPIRE,” Sharon Barr, AstraZeneca’s executive vice president of BioPharmaceuticals R&D, said.
TEZSPIRE is approved to treat severe asthma in the US, European Union, China, Japan and more than 70 countries. It is also approved for chronic rhinosinusitis with nasal polyps in the US, EU, China and Japan.
AstraZeneca and Amgen are pursuing another potential expansion of the drug through the Phase III JOURNEY and EMBARK trials in chronic obstructive pulmonary disease, which remain underway.
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