Celldex Therapeutics (CLDX) Status Update summary

Disease background and unmet need

• Chronic inducible urticaria (CIndU) is a difficult-to-treat condition affecting about 0.5% of the population, with no approved therapies beyond antihistamines, leading to impaired quality of life and high healthcare utilization.

• Patients experience high rates of anxiety, depression, and frequent medical visits, with poor response to standard antihistamines.

• Mast cell activation is a key driver of CIndU, and barzolvolimab targets KIT, a receptor critical for mast cell function.

Study design and patient characteristics

• The phase 2 study was randomized, double-blind, placebo-controlled, enrolling 196 patients with cold urticaria or symptomatic dermographism, most refractory to antihistamines.

• Patients received barzolvolimab 150 mg Q4W, 300 mg Q8W, or placebo for 20 weeks, with a 24-week follow-up and open-label extension.

• Baseline demographics were well balanced across groups, and enrollment was efficient across 11 countries.

Efficacy results and clinical impact

• Barzolvolimab met all primary and secondary endpoints with high statistical significance, achieving up to 53.1% complete response in cold urticaria and 57.6% in symptomatic dermographism at 12 weeks, compared to 12.5% and 3.2% for placebo.

• Up to 75% of cold urticaria and 67% of symptomatic dermographism patients achieved complete or partial response.

• Clinically meaningful improvements in provocation thresholds, itch reduction, and urticaria control were observed, with rapid onset as early as two weeks.

• Barzolvolimab demonstrated benefit in patients refractory to omalizumab and dupilumab, with consistent responses across subgroups.

• The drug is positioned as a potential first-in-class therapy for CIndU, addressing a significant unmet need.