Celldex Presents Data Demonstrating Barzolvolimab Improves Chronic Spontaneous Urticaria Independent of Baseline Immunoglobulin E levels in Phase 2 Study at EADV Congress 2025

Core Insights - Celldex announced new data showing the efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), demonstrating significant improvement regardless of baseline immunoglobulin E (IgE) levels [1][3][5] Group 1: Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - Complete response rates (UAS7=0) were observed in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks, with 41% of patients reporting a complete response at 76 weeks [5][8] - The study demonstrated similar efficacy in patients with low (<40) and normal/high (>40) IgE levels, reinforcing the role of mast cells in CSU [8][9] Group 2: Mechanism and Treatment Potential - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The drug shows promise as a treatment for all patients with moderate to severe CSU, particularly those with low IgE levels who typically respond poorly to existing therapies [3][8] Group 3: Ongoing Research and Development - Celldex is currently enrolling patients in a global Phase 3 program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] - The ongoing studies also include patients who have not responded to biologic treatments, indicating a broad potential application for barzolvolimab [6][10] Group 4: Background on CSU - Chronic spontaneous urticaria (CSU) is characterized by hives or wheals lasting for 6 weeks or longer without identifiable triggers, often leading to significant patient discomfort and reduced quality of life [11] - Current therapies provide only symptomatic relief for some patients, highlighting the need for more effective treatments like barzolvolimab [11]