AstraZeneca and Amgen's Tezspire meets Phase 3 goals in eosinophilic esophagitis

AstraZeneca and Amgen announced that their monoclonal antibody Tezspire met all primary and secondary goals in the Phase 3 CROSSING trial for eosinophilic esophagitis (EoE), a chronic inflammatory disease affecting 470,000 Americans. The trial of 368 patients demonstrated statistically significant improvements in esophageal eosinophil counts and swallowing difficulty over 52 weeks. If approved, EoE would become Tezspire's third indication, positioning it to compete directly with Sanofi and Regeneron's blockbuster drug Dupixent.

Tezspire Phase 3 EoE results

• ▪The primary goals of the Phase 3 CROSSING trial evaluated esophageal eosinophil count and swallowing difficulty at 24 weeks, with clinical improvements sustained over one year
• ▪The Phase 3 CROSSING trial of Tezspire in eosinophilic esophagitis enrolled 368 patients aged 12 to 80, comparing high and low doses of the drug against a placebo
• ▪AstraZeneca and Amgen announced on August 27, 2026, that their drug Tezspire met all primary and secondary objectives in the Phase 3 CROSSING trial for eosinophilic esophagitis
• ▪AstraZeneca and Amgen reported that the safety profile of Tezspire in the Phase 3 CROSSING trial was generally consistent with the drug's previously approved indications

Eosinophilic esophagitis treatment options

• ▪Standard treatments for eosinophilic esophagitis include proton pump inhibitors, swallowed topical corticosteroids, and dietary changes, though approximately half of patients do not respond to initial therapies
• ▪Sanofi and Regeneron's Dupixent is currently the only FDA-approved biologic drug for the treatment of eosinophilic esophagitis
• ▪Eosinophilic esophagitis is an inflammatory condition affecting an estimated 470,000 people in the United States, characterized by the buildup of white blood cells in the esophagus

Tezspire global sales projections

• ▪William Blair analyst Matt Phipps models global Tezspire sales of approximately $2.7 billion in 2026 and $3.3 billion in 2027, based solely on currently approved indications
• ▪AstraZeneca recorded $390 million in Tezspire sales in the second quarter of 2026, representing a 45% increase compared to the same period in 2025

TSLP antibody mechanism

• ▪Tezspire is currently approved as a maintenance treatment for severe asthma and chronic rhinosinusitis with nasal polyps
• ▪Tezspire is a monoclonal antibody designed to bind to and block thymic stromal lymphopoietin, a signaling protein implicated in epithelial-driven inflammatory conditions

AstraZeneca-Amgen collaboration terms

• ▪Under their collaboration agreement, Amgen holds United States commercialization rights to Tezspire, while AstraZeneca records sales for the rest of the world
• ▪Tezspire was initially discovered by Amgen, and AstraZeneca now leads the clinical development of the drug for additional indications, including chronic obstructive pulmonary disease

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