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Celldex Therapeutics Initiates Global Phase 3 Program for Barzolvolimab in Patients with Chronic Spontaneous Urticaria
Celldex TherapeuticsCelldex Therapeutics(US:CLDX) Newsfilterยท2024-07-16 12:01

Core Viewpoint - Celldex Therapeutics has initiated a global Phase 3 program for barzolvolimab, targeting chronic spontaneous urticaria (CSU) patients who remain symptomatic despite existing treatments [1][4]. Group 1: Clinical Trials - The Phase 3 program includes two trials, EMBARQ-CSU1 and EMBARQ-CSU2, enrolling over 1800 patients with CSU [1]. - Both trials are randomized, double-blind, placebo-controlled studies, with approximately 915 patients randomized to receive either barzolvolimab 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo for 52 weeks [3]. - The primary endpoint is to evaluate the reduction in urticaria activity (UAS7) at Week 12, with a focus on detecting clinically meaningful differences between active arms and placebo [3]. Group 2: Treatment Mechanism and Efficacy - Barzolvolimab is a novel monoclonal antibody that targets mast cells by blocking the receptor tyrosine kinase KIT, which is essential for mast cell function and survival [2][7]. - Previous studies have shown that barzolvolimab can provide rapid, durable, and complete disease control in CSU patients, regardless of their treatment history [3]. - A Phase 2 study indicated that barzolvolimab met its primary endpoint, showing statistically significant improvement in UAS7, along with favorable results in secondary endpoints such as itch severity and hives severity scores [4]. Group 3: Company Overview - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory and allergic diseases [8]. - The company aims to advance barzolvolimab not only for CSU but also for additional indications, including chronic inducible urticaria and atopic dermatitis [7][8].