Celldex Therapeutics(US:CLDX) GlobeNewswire News Roomยท2025-05-05 20:01Core Insights - Celldex announced histology data from its ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating a potential therapeutic benefit due to the correlation between intraepithelial mast cells and eosinophil counts [1][2] - The Phase 2 "EvolvE" study aims to test the hypothesis that barzolvolimab can deplete esophageal mast cells and lead to clinical improvement in EoE, a condition with limited treatment options [3][5] Study Details - The ongoing 28-week, randomized, double-blind, placebo-controlled study evaluates 300 mg of barzolvolimab or placebo administered every 4 weeks to participants with known EoE [3] - The primary endpoint is the reduction in peak esophageal epithelial mast cell count at 12 weeks, with key secondary endpoints including reduction in peak eosinophil count and dysphagia symptom scores [3] - Screening data from 151 participants show high numbers of intraepithelial mast cells in active EoE cases, correlating with eosinophil counts [3] Eosinophilic Esophagitis (EoE) Overview - EoE is characterized by chronic inflammation of the esophagus due to eosinophil infiltration, leading to symptoms such as difficulty swallowing and chest pain [5] - Current treatment options for EoE are limited, highlighting the importance of developing effective therapies like barzolvolimab [5] Barzolvolimab Profile - Barzolvolimab is a humanized monoclonal antibody targeting the receptor tyrosine kinase KIT, which is involved in mast cell activity and inflammatory responses [6] - The drug is also being studied for other conditions, including chronic spontaneous urticaria and atopic dermatitis, indicating its broader therapeutic potential [6] Company Background - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the immune system and target critical pathways for severe inflammatory and allergic diseases [7]