Celldex Reports Phase 2 Topline Results For Barzolvolimab In Eosinophilic Esophagitis; Says Study Met Primary Endpoint Demonstrating Barzolvolimab's Ability To Potently Deplete Mast Cells In Gastrointestinal Tract

Author: Benzinga Newsdesk | August 19, 2025 04:03pm

Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported topline results from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. Identifying the key drivers of EoE has challenged the field and research has suggested that mast cells could play an important role in the disease pathogenesis. Celldex designed this study to determine if barzolvolimab could deplete mucosal (intraepithelial) mast cells and, in turn, improve clinical outcomes in EoE. The primary endpoint of the study, absolute change from baseline to Week 12 in peak esophageal intraepithelial mast cell count was met, but the profound mast cell depletion observed did not result in improvement in EoE symptoms or endoscopic assessment of disease activity compared to placebo. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile. Based on these results, Celldex will not advance development in EoE. The results do support future development with KIT- or SCF-targeted therapies in other GI indications where mucosal mast cells are believed to play an important role.

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