Celldex Therapeutics Advances Phase 3 Trial for Chronic Spontaneous Urticaria Treatment with Barzolvolimab

Celldex Therapeutics has announced an update on its ongoing Phase 3 clinical trial for chronic spontaneous urticaria treatment. The trial is evaluating the efficacy, safety, and tolerability of barzolvolimab, a biological treatment administered subcutaneously. The study aims to improve symptoms in patients who have limited relief from existing medications. The outcome of this study could impact Celldex Therapeutics' stock performance and the competitive landscape in the dermatology and immunology sectors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) has recently provided an update on its ongoing Phase 3 clinical trial for chronic spontaneous urticaria (CSU) treatment. The trial is evaluating the efficacy, safety, and tolerability of barzolvolimab, a biological treatment administered subcutaneously. The study aims to improve symptoms in patients who have limited relief from existing medications. The outcome of this study could significantly impact Celldex Therapeutics' stock performance and the competitive landscape in the dermatology and immunology sectors.

The Phase 3 trial, known as EMBARQ-CSU1 and EMBARQ-CSU2, began in July 2025 and is recruiting adult patients with CSU who remain symptomatic despite receiving either H1 antihistamine treatment or biologics. The trial is expected to continue with further late-stage studies approaching in the second half of 2025, targeting patients with chronic inducible urticaria (CIndU).

Barzolvolimab has shown promising results in previous Phase 2 studies, achieving the intended primary and secondary endpoints over a 12-week period. The drug also demonstrated a high response rate of 41% and improved quality of life (QoL) for CSU patients over a 72-week period. Furthermore, nearly half of the patients reported no impact on their QoL, and a significant majority were angioedema-free at Week-52.

The company is also gearing up to report 20-week data from a Phase 2 trial targeting patients with CIndU at an upcoming medical conference in the second half of 2025. Additionally, Celldex is exploring the use of barzolvolimab for other inflammatory skin disorders, such as prurigo nodularis (PN) and atopic dermatitis (AD).

Despite the setback in treating eosinophilic esophagitis (EoE) patients, Celldex remains optimistic about the future of barzolvolimab. The company's focus on CSU and CIndU, along with its ongoing studies, indicates a strong commitment to developing innovative treatments in the dermatology and immunology sectors.

References:
[1] https://seekingalpha.com/article/4815782-celldex-despite-dropping-eosinophilic-esophagitis-program-barzolvolimab-on-track