AstraZeneca and Amgen announced that Tezspire, a biologic drug, successfully met primary endpoints in a phase 3 trial for eosinophilic esophagitis, demonstrating significant improvements in disease remission and swallowing difficulties that were sustained over 52 weeks of treatment.
- Tezspire met both co-primary endpoints in the CROSSING phase 3 trial, showing statistically significant improvements in histologic remission and reduction in dysphagia compared to placebo.
- Eosinophilic esophagitis affects more than 470,000 people in the United States, with nearly half failing to achieve adequate control with current first-line therapies.
- Tezspire targets thymic stromal lymphopoietin (TSLP), a cytokine involved in multiple inflammatory pathways, representing a novel mechanism of action for this disease.
AstraZeneca and Amgen announced positive phase 3 trial results for its biologic drug Tezspire (tezepelumab). Officials with both companies addressed the details of the CROSSING trial in a press release and said the results potentially open the door to a new treatment option for patients suffering from eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.
According to the announcement, the phase 3 trial met both of its co-primary endpoints, demonstrating statistically significant and clinically meaningful improvements in disease remission and swallowing symptoms compared with placebo. Benefits were sustained through 52 weeks of treatment, reinforcing confidence in the drug’s long-term effectiveness, officials reported.
The study evaluated Tezspire in adults and adolescents with symptomatic, uncontrolled EoE. Participants received subcutaneous injections every four weeks. Researchers found that patients treated with the drug achieved higher rates of histologic remission, measured by reductions in eosinophil counts in esophageal tissue, while also experiencing significant reductions in dysphagia, or difficulty swallowing, a hallmark symptom of the disease.
“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, a gastroenterologist at Amsterdam University Medical Center in the Netherlands and the trial’s primary investigator. “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.”
According to the press release, EoE affects more than 470,000 people in the United States, with prevalence increasing dramatically over the past decade. Researchers noted that the disease causes inflammation and narrowing of the esophagus, making eating difficult and increasing the risk of food becoming lodged in the throat. Nearly half of patients fail to achieve adequate control with current first-line therapies, such as dietary modifications, proton pump inhibitors and oral corticosteroids, they said.
For AstraZeneca, the results represent another significant milestone for Tezspire, which is already approved in more than 70 countries for severe asthma and in several markets for chronic rhinosinusitis with nasal polyps. AstraZeneca reported that the positive trial marks the third epithelial-driven inflammatory disease in which the therapy has demonstrated meaningful clinical benefit.
Sharon Barr, executive vice president of biopharmaceuticals R&D at AstraZeneca, said the findings validate the drug’s unique mechanism of action targeting thymic stromal lymphopoietin (TSLP), a cytokine involved in multiple inflammatory pathways. The company said it planned to share full trial data with regulators and present detailed findings at an upcoming scientific meeting. Regulatory submissions are expected to follow news of the results.
The randomized, double-blind trial enrolled 368 patients aged 12 to 80 and compared two dose levels of Tezspire with placebo. Patients were allowed to remain on stable background therapies throughout the study. In addition to improvements in tissue inflammation and swallowing symptoms, investigators observed favorable results across several secondary endpoints evaluating disease severity and endoscopic findings.
