Celldex Initiates Phase 2 Study of Barzolvolimab in Atopic Dermatitis

Core Viewpoint - Celldex Therapeutics has initiated a Phase 2 study of barzolvolimab for atopic dermatitis, addressing a significant unmet need in the treatment of this common chronic inflammatory skin disease [1][2][3] Group 1: Study Details - The Phase 2 study is randomized, double-blind, and placebo-controlled, evaluating the efficacy and safety of subcutaneous barzolvolimab in patients with moderate to severe atopic dermatitis [2] - Approximately 120 patients will be enrolled, receiving either 150 mg or 300 mg of barzolvolimab or a placebo every 4 weeks after an initial loading dose [2] - The primary endpoint is to assess clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, with secondary endpoints including various patient-reported outcomes [2][3] Group 2: Disease Background - Atopic dermatitis affects up to 20% of the US population, with a significant impact on quality of life, as many patients experience severe itching and skin breakdown [1][3] - Up to 50% of adult patients have moderate to severe disease, and 86% experience daily pruritus, with 61% reporting severe or unbearable itching [3] Group 3: Barzolvolimab Overview - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function and survival [4] - The drug is also being studied for other conditions, including chronic spontaneous urticaria and eosinophilic esophagitis, indicating its potential versatility in treating mast cell-related diseases [4] Group 4: Company Background - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the immune system and target critical pathways for severe inflammatory and allergic diseases [5]