Celldex Therapeutics(US:CLDX) Globenewswire·2025-11-06 13:00Core Insights - Celldex announced new data on barzolvolimab's efficacy in chronic spontaneous urticaria (CSU) at the ACAAI Annual Scientific Meeting, highlighting its potential to transform treatment for patients suffering from this debilitating condition [1][2] Study Results - The Phase 2 study met its primary endpoint, showing significant improvement in UAS7 scores compared to placebo at 12 weeks across all dose groups [4] - Barzolvolimab achieved rapid complete response rates (UAS7=0) in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks [4] - Seven months post-treatment, 41% of patients reported a complete response, and 48% indicated their quality of life was no longer affected by the disease [4] - Patients on barzolvolimab experienced an average improvement of 8.6 points in UCT7 scores from baseline at Week 12, compared to 2.5 points for placebo [7] - At Week 52, 71% of patients achieved complete disease control (UCT7=16) and 86% achieved well-controlled disease (UCT7>12) at the 150 mg Q4W dose [7] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile, with mild side effects such as hair color changes and skin hypopigmentation being reversible after treatment discontinuation [4][7] Ongoing Research - The company is currently enrolling patients in a global Phase 3 Program for barzolvolimab, consisting of two trials aimed at establishing its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [5][10] Background on CSU - Chronic spontaneous urticaria (CSU) is characterized by hives or wheals lasting six weeks or longer without identifiable triggers, often leading to significant patient discomfort and reduced quality of life [11]