AstraZeneca and Amgen said Tezspire met both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in patients with eosinophilic esophagitis, supporting plans to share the results with regulators.
Tezspire, or tezepelumab, demonstrated statistically significant and clinically meaningful improvements versus placebo at Week 24 in histologic remission and the frequency and severity of dysphagia, or difficulty swallowing. The benefits were sustained through Week 52 at both doses tested, the companies said.
CROSSING was a randomized, double-blind, placebo-controlled Phase 3 study that enrolled 368 patients aged 12 to 80 with symptomatic and histologically active eosinophilic esophagitis. Participants were randomized equally to receive a low dose of Tezspire, a high dose of Tezspire or placebo, administered subcutaneously every four weeks.
The trial’s first co-primary endpoint assessed histologic remission, defined as a peak eosinophil count of six or fewer per high-power field in esophageal tissue. The second measured changes from baseline in dysphagia using the patient-reported Dysphagia Symptom Questionnaire.
Key secondary measures included histologic remission and dysphagia symptoms at Week 52; changes in endoscopic disease features and histologic severity at Weeks 24 and 52; and endoscopic response, inflammatory remission and total endoscopic remission at Week 52.
Patients were permitted to continue stable background treatments, including proton-pump inhibitors and swallowed topical corticosteroids, during the study.
Eosinophilic esophagitis is a chronic, progressive inflammatory disorder of the esophagus. AstraZeneca said the condition affects more than 470,000 people in the United States, with prevalence increasing fivefold since 2009. Inflammation can lead to swallowing difficulties, food impaction and narrowing of the esophagus.
Nearly half of patients, including adolescents, do not achieve adequate disease control with first-line options such as dietary restriction, swallowed topical corticosteroids and proton-pump inhibitors, the companies said.
Tezspire is a monoclonal antibody that inhibits thymic stromal lymphopoietin, an epithelial cytokine involved in multiple inflammatory cascades. It is approved for severe asthma in more than 70 countries and for chronic rhinosinusitis with nasal polyps in the U.S., European Union, China and Japan.
AstraZeneca and Amgen said they will present full CROSSING results at an upcoming medical meeting and submit them to regulatory authorities.
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