AstraZeneca and Amgen's Tezspire Succeeds in Phase III Trial for Eosinophilic Esophagitis

On Thursday, AstraZeneca and Amgen announced top-line data from the Phase III CROSSING trial of Tezspire administered subcutaneously every four weeks versus placebo in patients with symptomatic and histologically active eosinophilic esophagitis.

Tezspire Shows Significant Improvements

EoE is a chronic, immune-mediated inflammatory disease in which white blood cells called eosinophils accumulate in the lining of the esophagus, causing damage and difficulty swallowing.

EoE affects more than 470,000 people in the United States, with prevalence increasing fivefold since 2009.

Data showed that at week 24, Tezspire demonstrated statistically significant and clinically meaningful improvements on both co-primary endpoints and all key secondary endpoints, with improvements sustained through week 52 at both tested doses.

The co-primary endpoints were histologic remission and frequency and severity of dysphagia compared with placebo. The safety profile of Tezspire in the trial was generally consistent with its approved indications.

"The impressive 52-week results from the CROSSING trial suggest that tezepelumab dosed once every four weeks could offer a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement," said Arjan Bredenoord, principal investigator of the trial.

Already Approved for Severe Asthma and Nasal Polyps

Tezspire is a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin, a key epithelial cytokine at the top of multiple inflammatory cascades.

The drug is currently approved for severe asthma in the U.S., EU, China, Japan, and more than 70 countries globally, and for chronic rhinosinusitis with nasal polyps in the U.S., EU, China, and Japan.

Phase III JOURNEY and EMBARK trials evaluating Tezspire for chronic obstructive pulmonary disease are ongoing.

AMGN/AZN stock movement: In premarket trading Thursday, Amgen shares fell 1.49% to $433.80, while AstraZeneca shares fell 0.63% to $165.22.