Celldex Therapeutics announced that enrollment in its two global Phase 3 studies of barzolvolimab for chronic spontaneous urticaria (CSU) has been completed. The EMBARQ‑CSU1 and EMBARQ‑CSU2 trials now include 1,939 patients across 43 countries and more than 500 sites, a full six months ahead of the original schedule.
The accelerated enrollment underscores the high unmet need for effective treatments in antihistamine‑refractory CSU. By enrolling patients at a rate that outpaces the industry average, Celldex demonstrates strong engagement from physicians and patients, positioning barzolvolimab as a potential best‑in‑disease therapy that targets mast cells via KIT inhibition, a mechanism distinct from the IgE‑targeting omalizumab.
Both trials are randomized, double‑blind, placebo‑controlled studies that evaluate two dosing regimens—150 mg every four weeks or 300 mg every eight weeks—over 52 weeks. Placebo‑treated patients are re‑randomized to active therapy at week 24, allowing the study to assess both short‑term efficacy and long‑term durability of response.
Celldex expects topline data from the two studies in the fourth quarter of 2026, with a Biologics License Application slated for 2027. The company’s regulatory strategy relies on the robust enrollment and the promising Phase 2 data, which showed up to 71 % of patients achieving complete response at 52 weeks and sustained response in 41 % of patients seven months after the last dose.
Anthony S. Marucci, Co‑founder, President and CEO, said the early enrollment “highlights the significant unmet need in CSU and speaks to the excitement from patients and physicians about barzolvolimab and its potential as a best‑in‑disease treatment.” Senior Vice President and Chief Medical Officer Diane C. Young added that the Phase 2 results “demonstrate a level of complete disease control that is unprecedented in CSU, reinforcing barzolvolimab’s potential to transform the treatment landscape.”
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