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Celldex Presents Histology Data from Phase 2 Study of Barzolvolimab in EoE Supporting Potential of Mast Depleting Agent in this Difficult to Treat Disease
Phase 2 study fully enrolled; data expected in 2H 2025 HAMPTON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Celldex announced today the presentation of histology
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"Phase 2 study fully enrolled; data expected in 2H 2025\nHAMPTON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Celldex announced today the presentation of histology data from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. The data were discussed in a poster presentation at the Digestive Disease Week (DDW) 2025 conference in San Diego today. Celldex announced in February 2025 that enrollment to the Phase 2 study is complete and that clinical results are expected in the second half of 2025. “These data continue to add to a growing body of literature suggesting that eosinophilic esophagitis involves more than just eosinophils and that mast cells play an important role in the disease process,” said Evan S. Dellon, MD, MPH, Professor of Medicine and Director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine and the lead author of the poster. “This is further supported by previous findings that mast cells are present in the biopsy tissue of some patients who continue to suffer from EoE even after eosinophils have been depleted. Barzolvolimab has been shown to deplete cutaneous mast cells and we believe it will likely also deplete esophageal mast cells, which could lead to clinical improvement in EoE—an indication that sorely needs additional effective treatment options. I look forward to seeing the clinical data from the study later this year.” EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils. Chronic inflammation can result in trouble swallowing, chest pain, vomiting and impaction of food in the esophagus – a medical emergency. Several studies have suggested that mast cells may be an important driver in the disease. Mast cells are present and activated in the esophageal epithelium of EoE biopsy specimens1-11, are important sources of inflammatory cytokines2,9 and are associated with disease features of EoE including histolog...