Celldex Therapeutics Pulls Plug On Eosinophilic Esophagitis Investigational Drug As Data Falls Short

Core Insights - Celldex Therapeutics, Inc. announced topline results from its Phase 2 study of barzolvolimab for eosinophilic esophagitis (EoE), meeting the primary endpoint of mast cell depletion but failing to show clinical improvement in symptoms [1][2][6] Study Results - The study aimed to assess the effect of barzolvolimab on intraepithelial mast cells and clinical outcomes in EoE [1] - The primary endpoint was met with a significant reduction in peak esophageal intraepithelial mast cell count, showing an absolute change from baseline of -36.0 for barzolvolimab compared to -2.7 for placebo at Week 12 [5][6] - Despite the significant mast cell depletion, no improvement in EoE symptoms was observed, with p-values of 0.33 for the Dysphagia Symptom Questionnaire and 0.95 for endoscopic scoring [6][7] Safety Profile - Barzolvolimab exhibited a favorable safety and tolerability profile consistent with previous studies [2][7] - The dosing regimen of 300 mg Q4W was well-tolerated, showing no significant adverse effects compared to less frequent dosing in earlier studies [7] Future Directions - Following these results, Celldex will not pursue further development of barzolvolimab for EoE but will continue to advance its pipeline, including ongoing studies in chronic spontaneous urticaria and plans for a Phase 3 program in inducible urticaria [3][4]