Celldex Therapeutics (CLDX) Status Update summary

Study results and clinical impact

• Barzolvolimab achieved statistically significant and clinically meaningful results in a large, randomized, placebo-controlled phase 2 study for chronic inducible urticaria (CIndU), meeting all primary and secondary endpoints at 12 weeks.

• High rates of complete response were observed: up to 53% in cold urticaria and 58% in symptomatic dermographism at week 12, significantly higher than placebo.

• Improvements were rapid, with benefits seen as early as two weeks and sustained through the 12-week period, including reductions in itch and improved urticaria control scores.

• Barzolvolimab demonstrated efficacy in patients refractory to other biologics and antihistamines, including omalizumab and dupilumab.

• Quality of life measures, such as the Urticaria Control Test, showed marked improvement, with up to 70% of patients reporting well-controlled disease.

Safety and tolerability

• Barzolvolimab was well tolerated, with 98% of treatment-emergent adverse events being mild to moderate; most common were hair color changes (up to 13%) and neutropenia (up to 10%), both mild and reversible.

• Discontinuation due to adverse events was low and similar to placebo.

• No evidence of anaphylaxis was found, and infection rates were similar to placebo, with no link between neutropenia and infections.

Study design and patient characteristics

• The phase 2 study was randomized, double-blind, placebo-controlled, and dose-finding, enrolling 196 patients with cold urticaria or symptomatic dermographism across 11 countries.

• Patients received barzolvolimab 150 mg Q4W, 300 mg Q8W, or placebo for 20 weeks, with primary endpoint at 12 weeks; baseline demographics were well balanced.

• Enrollment was efficient, and future phase 3 studies are expected to be smaller and rapidly accrued.