Celldex Therapeutics Presents Positive Results from Barzolvolimab Phase 2 Studies in Patients with Chronic Urticaria Demonstrating Improved Disease Control and Quality of Life at AAAAI 2025

Core Insights - Celldex Therapeutics, Inc. announced positive results from Phase 2 studies of barzolvolimab, showing significant improvements in disease control and quality of life for patients with chronic urticaria [1][2][3] Group 1: Study Results - In the Phase 2 CSU study, 82% of patients reported that symptoms no longer impacted their quality of life at Week 52 [1][7] - In the Phase 2 CIndU study, 60% of patients reported that symptoms no longer impacted their quality of life at Week 12 [1][7] - Up to 71% of CSU patients achieved complete response (UAS7 = 0) at Week 52, the highest rate observed in a well-controlled study [7] - Up to 95% of CSU patients reported meaningful improvement in quality of life based on the Dermatology Life Quality Index (DLQI) at Week 52 [7] - Up to 82% of CSU patients reported well-controlled urticaria based on the Urticaria Control Test (UCT) at Week 52 [7] - In the CIndU study, up to 60% of patients reported that symptoms no longer impacted their quality of life at Week 12, with 69% reporting well-controlled urticaria based on UCT [7] Group 2: Treatment Implications - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function and survival [1][14] - The treatment has the potential to change the treatment paradigm for chronic urticaria, allowing patients to live normally again [3] - Current clinical guidelines emphasize complete disease control as the treatment goal, with studies showing minimal or no impact on quality of life when this is achieved [3] Group 3: Future Developments - Global Phase 3 studies for barzolvolimab in patients with CSU are actively enrolling, with plans to advance into Phase 3 development for CIndU in 2025 [6]