On Thursday, AstraZeneca Plc (NYSE:PLC) and Amgen Inc. (NASDAQ:AMGN) shared topline data from the Phase 3 CROSSING trial of Tezspire (tezepelumab) administered subcutaneously every four weeks, compared to placebo in symptomatic and histologically active eosinophilic esophagitis (EoE) patients.
Tezspire Shows Significant Improvements
EoE is a chronic, immune-mediated inflammatory disease where white blood cells called eosinophils build up in the lining of the esophagus (a muscular tube that connects the throat to the stomach to transport food and liquid), causing damage and difficulty swallowing.
EoE affects more than 470,000 people in the U.S., with the prevalence increasing fivefold since 2009.
Data showed that Tezspire demonstrated statistically significant and clinically meaningful improvements across both co-primary and all key secondary endpoints at week 24, which were sustained through week 52 in both doses tested.
The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing) compared to placebo. The safety profile of Tezspire in the trial was generally consistent with its approved indications.
“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 EoE, with the potential to help more patients achieve remission and symptom improvement,” said Arjan Bredenoord, primary investigator in the trial.
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 that sits 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 across the globe, and for chronic rhinosinusitis with nasal polyps in the U.S., EU, China, and Japan.
The Phase 3 JOURNEY and EMBARK trials evaluating Tezspire in chronic obstructive pulmonary disease are ongoing.
AMGN/AZN Stock Price Activity: Amgen shares were down 1.49% at $433.80, and AstraZeneca shares were down 0.63% at $165.22 during premarket trading on Thursday, according to Benzinga Pro data.
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