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Celldex Therapeutics Presents Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria
Met primary endpoint demonstrating clinically meaningful and statistically significant complete response rate across both dose groupsFirst large, randomized,
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"Met primary endpoint demonstrating clinically meaningful and statistically significant complete response rate across both dose groupsFirst large, randomized, placebo-controlled study to demonstrate success in CIndU Favorable safety and tolerability consistent with prior studies Plans to advance CIndU into Phase 3 registration developmentCompany to host webcast call today at 4:30 pm ET HAMPTON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. “Barzolvolimab is the first drug in development to demonstrate statistically significant and clinically meaningful results in a large, randomized, placebo-controlled study in chronic inducible urticaria. These data are unprecedented and clearly demonstrate that barzolvolimab has the potential to become a critically needed new treatment option for patients suffering from this disease,” said Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. “Inducible urticaria is a disease of misery for patients who despite their best efforts often find it impossible to avoid their disease triggers and are impacted by severe itching and burning hives that dramatically impact all aspects of their lives. We look forward to advancing barzolvolimab into registrational studies in inducible urticaria and moving towards our goal of bringing this potential new medicine to patients. We would like to thank the patients and investigators who participated in this study and look forward to presenting the full 12 week data from this study at an upcoming medical meeting...