Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025

Published: 2025-06-12 22:05:40 ET CLDX

Published on 06/12/2025 at 22:05

Celldex announced new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with 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 being presented in a late breaking oral presentation (#100227) at the EAACI Congress 2025.

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--ac across all dose groups tested. Barzolvolim AB demonstrated a well tolerated safety profile throughout the study. By addressing the root driver of chronic spontaneous urticaria, the mast cell, barzolvolimab provided meaningful clinical benefit to more than 90% of the patients on study, including patients with severe disease refractory to omalizumab, and demonstrated a level of sustained complete response after the completion of active therapy that is unprecedented in CSU.

48% of patients treated with barzolvolim AB 150 mg Q4W and 40% of patients treated with 300 mg Q8W reported that CSU had no impact on their quality of life at 76 weeks as measured by the Dermatology Life Quality Index (DLQI). Current clinical guidelines recommend complete response (UAS7=0) as the goal of treatment and achieving complete response is directly correlated to the greatest improvements in quality of life for patients. These robust responses and improvements in quality of life were observed regardless of prior omalizumab experience.