Celldex presents positive Phase 1b interim data from barzolvolimab in urticaria

Celldex announced new data from the company’s open label Phase 1b clinical trial of barzolvolimab in patients with antihistamine refractory chronic inducible urticarias are being presented at the GALEN Global Urticaria Forum in Berlin. All 9 of 9 – 100% – cold urticaria patients who received a 1.5 mg/kg single full dose of barzolvolimab experienced a complete response as assessed by provocation testing, including 4 of 4 patients with omalizumab refractory disease. This cohort was added to the Phase 1b trial in patients with chronic inducible urticaria after Celldex previously reported a 95% complete response rate in July 2021 in patients with antihistamine-refractory cold urticaria and symptomatic dermographism who received a single 3.0 mg/kg dose of barzolvolimab. The company also added an optional long term follow up evaluation for the initial cohorts of patients treated at 3.0 mg/kg beyond the original 12 week follow up period out to 36 weeks and confirmed that barzolvolimab-induced response and mast cell suppression are durable and linked. A randomized, double-blind, placebo-controlled, multi-dose Phase 2 subcutaneous study of barzolvolimab is currently enrolling patients with both cold urticaria and symptomatic dermographism.