Celldex Completes Patient Enrollment in Phase 2 Barzolvolimab Trial for Chronic Inducible Urticaria

Celldex Therapeutics, Inc., a clinical-stage biotechnology firm, has achieved a significant milestone in its Phase 2 clinical trial for barzolvolimab, a potential treatment for chronic inducible urticaria (CIndU). The study has successfully enrolled all required patients, focusing on cold urticaria (ColdU) and symptomatic dermographism (SD), two prevalent forms of CIndU. This condition is characterized by hives or wheals that are triggered by specific stimuli, such as cold temperatures in ColdU and skin irritation in SD.

Barzolvolimab is a monoclonal antibody designed to target the receptor tyrosine kinase KIT, which is crucial for the function and survival of mast cells, known to be a key factor in the development of CIndU. The treatment's efficacy and safety are being evaluated in patients who continue to experience symptoms despite antihistamine therapy. The trial, which is randomized, double-blind, and placebo-controlled, involves two cohorts of patients, with 196 participants in total. They are receiving either 150 mg of barzolvolimab every four weeks, 300 mg every eight weeks, or a placebo, over a 20-week treatment period, followed by a 24-week follow-up.

The primary goal of the study is to determine the percentage of patients who show a negative provocation test at Week 12, utilizing TempTest® for ColdU and FricTest® for SD. Secondary endpoints encompass safety assessments and various clinical activity measures, including critical temperature threshold, critical friction threshold, and worst itch numeric rating scale.

Anthony Marucci, President and CEO of Celldex Therapeutics, expressed gratitude to the investigators and patients involved in the trial. He highlighted the significant impact of CIndU on patients' quality of life and the lack of approved therapies beyond antihistamines. Marucci emphasized the company's belief in barzolvolimab's potential as a transformative treatment for CIndU patients and anticipated sharing the study's topline data later in the year.

CIndU affects approximately 0.5% of the population, and patients often struggle to manage their symptoms through trigger avoidance. Barzolvolimab is also being investigated for other conditions, including chronic spontaneous urticaria, prurigo nodularis, and eosinophilic esophagitis.

Celldex Therapeutics is dedicated to advancing mast cell biology and developing innovative therapeutics for severe inflammatory, allergic, autoimmune, and other serious diseases. The company's pipeline includes antibody-based treatments aimed at engaging the immune system or directly influencing critical pathways to improve patient outcomes.