Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025

• 77% of patients (150 mg Q4W) treated with barzolvolimab who had angioedema at baseline were angioedema free at Week 52
• Data further support barzolvolimab clinical benefit to patients with CSU

HAMPTON, N.J., June 14, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but can also involve the tongue, uvula, soft palate, and pharynx¹.

The data were presented today by Dr. Martin Metz, Professor, Department of Dermatology and Allergy, Head of Translational Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin, in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025. Celldex previously announced that the Phase 2 study in CSU met its primary and secondary endpoints at 12 weeks with clinically meaningful and statistically significant decreases in UAS7 (weekly urticaria activity score) compared to placebo across multiple dose groups, including improvements in quality of life and angioedema measurements, and demonstrated a favorable safety profile. The data presented today further support these results by demonstrating improvements in AAS7 (weekly angioedema activity score) and additional measures of angioedema control over the 52 week treatment period. AAS7 measures the frequency and intensity of angioedema episodes, where higher scores indicate increased angioedema activity.

“The majority of patients with severe CSU suffer with angioedema, which is often extremely painful and causes disfigurement, dramatically impacting quality of life,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Consistent with previously reported clinical outcomes, we observed rapid, profound angioedema relief with barzolvolimab treatment and this benefit continued to improve over 52 weeks of therapy for patients. These data add to the unprecedented 76 week efficacy and safety data we presented yesterday at EAACI and continue to support barzolvolimab’s potential to redefine the treatment landscape and meet the goals of CSU therapy—rapid, profound, durable complete response and improved quality of life across a broad patient population.”