Celldex’s presents results for barzolvolimab in CIndU, ColdU and SD

Celldex Therapeutics announced positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria or CIndU-cold urticaria, ColdU, and symptomatic dermographism or 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. Data from the 196 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, a statistically significant difference between the percent of patients with a negative provocation test compared to placebo at Week 12 as assessed by the TempTest in ColdU and the FricTest in SD. Importantly, barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with CIndU refractory to antihistamines. Demographics and baseline disease characteristics were well balanced across treatment groups.