LONDON (dpa-AFX) - AstraZeneca (AZN) said Tuesday that full results from the Phase 3 CROSSING trial showed Tezspire improved disease remission and swallowing symptoms in adolescents and adults with eosinophilic esophagitis.
Tezspire, or tezepelumab, blocks thymic stromal lymphopoietin, a protein involved in inflammation.
The randomized, double-blind, placebo-controlled Phase 3 CROSSING trial enrolled 368 patients aged 12-80 with symptomatic and histologically active eosinophilic esophagitis. Patients were assigned equally to receive tezspire 210 mg, 420 mg or placebo by subcutaneous injection every four weeks.
The drug, developed with Amgen (AMGN), met both co-primary endpoints at week 24, with benefits sustained through week 52.
At week 24, histologic remission was achieved by 64.8% of patients receiving 210 mg and 68.9% receiving 420 mg, compared with 3.5% on placebo. Swallowing symptom scores improved by 18.8 and 22.0 points, respectively, versus 14.7 points with placebo.
At week 52, total endoscopic remission, meaning no visible disease features, occurred in 34.4% and 29.5% of patients receiving the respective doses, versus 4.1% on placebo.
Tezspire was administered every four weeks. Its safety profile was consistent with approved indications, with common adverse events including upper respiratory infection, headache and diarrhea.
AstraZeneca plans to share the data with regulatory authorities. The findings were presented at United European Gastroenterology Week, held October 17-20 in Barcelona.
AZN closed on Monday at $163.95, down 0.88%.
Currently, AZN is trading up 2.36% at $167.85.
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