- 71% of patients (150 mg Q4W) achieved complete response at Week 52 -

- Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks -

- Robust improvement across omalizumab-experienced/refractory/naïve disease -

- Well tolerated through 52 weeks -

- Enrollment to Global Phase 3 CSU trials underway -

- Company to host webcast today at 12:00 pm ET/6:00 pm CEST -

HAMPTON, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new data demonstrating sustained and deepening disease efficacy and a well tolerated safety profile over a 52 week treatment period for barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The data are bring presented today by Dr. Martin Metz, Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin in a late breaking oral presentation at the EADV Congress 2024. The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks—across all dose groups tested.