Celldex presented histology data from its Phase 2 trial of barzolvolimab for eosinophilic esophagitis (EoE) at the 2025 Digestive Disease Week conference. Biopsies from participants revealed high intraepithelial mast cell counts correlating with eosinophil counts, suggesting barzolvolimab, a mast cell depleting agent, may offer therapeutic benefit. The Phase 2 trial completed enrollment in February 2025, with results anticipated in the second half of 2025.
This research is potentially groundbreaking for EoE treatment. Current options are limited, and this data reinforces the emerging understanding of mast cells’ significant role in EoE. The correlation between mast cells and eosinophils strengthens the rationale for targeting mast cells with barzolvolimab, potentially offering a new therapeutic avenue for patients who often experience debilitating symptoms like difficulty swallowing, chest pain, and esophageal food impaction.
The Phase 2 “EvolvE” study is a 28-week, randomized, double-blind, placebo-controlled trial involving 300 mg of barzolvolimab or a placebo administered every four weeks to participants with EoE. The primary endpoint is the reduction in peak esophageal epithelial mast cell count at 12 weeks. Key secondary endpoints include reductions in peak eosinophil count and dysphagia symptom questionnaire (DSQ) scores at 12 weeks. Analysis of screening biopsies from 151 participants showed a strong correlation between mast cell and eosinophil counts.
Positive clinical data from the EvolvE study could significantly advance barzolvolimab as a potential treatment for EoE. This could position Celldex as a key player in addressing this unmet medical need and may lead to further research exploring the role of mast cells in other inflammatory diseases. The anticipated results hold considerable promise for patients and could reshape the therapeutic landscape for EoE.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
