Celldex Therapeutics(US:CLDX) Globenewswireยท2025-09-17 09:11Core Insights - Celldex announced new data showing rapid and strong efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), regardless of baseline immunoglobulin E (IgE) levels [1][3][8] Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks; 41% of patients reported a complete response at 76 weeks [5][8] - The study demonstrated a well-tolerated safety profile throughout the treatment period [5] Mechanism of Action - 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 data reinforces the role of mast cells as key drivers of CSU, indicating that barzolvolimab could be a meaningful treatment for all patients, including those with low IgE levels [3][8] Ongoing Research - 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] About Chronic Spontaneous Urticaria (CSU) - CSU is characterized by hives or wheals lasting 6 weeks or longer without identifiable triggers, often resulting from mast cell activation [11]