Celldex Therapeutics has launched a global Phase 3 study, EMBARQ‑ColdU and SD, to evaluate its lead antibody barzolvolimab in adults with cold urticaria and symptomatic dermographism who remain symptomatic despite antihistamine therapy. The trial will enroll roughly 240 participants across 75 sites in seven countries, with 120 patients in each cohort receiving either barzolvolimab 150 mg every four weeks after a 450 mg loading dose or a matching placebo for 24 weeks.
The primary endpoint is the percentage of patients achieving a complete response at week 12, measured by the TempTest® for cold urticaria and the FricTest® for symptomatic dermographism. The study design—double‑blind, placebo‑controlled, and randomized—provides a robust framework to assess barzolvolimab’s efficacy and safety in these two distinct mast‑cell–driven disorders.
Barzolvolimab targets the KIT receptor, a key driver of mast‑cell activation and survival. Phase 2 data showed high partial and complete response rates—up to 75 % in cold urticaria and 67 % in symptomatic dermographism at week 12—alongside a well‑tolerated safety profile. These results underscore a significant unmet need, as more than 533,000 patients in the U.S. and Europe are affected and over 80 % lack adequate disease control with current antihistamines.
The trial expands barzolvolimab’s portfolio beyond chronic spontaneous urticaria and chronic inducible urticaria, positioning Celldex to address a broader mast‑cell–driven disease spectrum. The potential market for barzolvolimab in these indications is estimated in the multi‑billion‑dollar range, reflecting the large patient population and the absence of approved advanced therapies. Successful Phase 3 outcomes could unlock a substantial revenue opportunity and reinforce Celldex’s focus on mast‑cell biology.
Celldex maintains a strong cash position with a runway projected through 2027, but recent earnings reports show widening net losses driven by increased R&D spending on late‑stage programs. The company’s financial strategy prioritizes funding for its pipeline, including the current Phase 3 trial and other ongoing studies in chronic spontaneous urticaria, prurigo nodularis, and atopic dermatitis.
CEO Anthony Marucci emphasized the company’s commitment to executing trials and delivering barzolvolimab to patients. Analysts have noted the Phase 3 launch as a significant de‑risking event for the program, reflecting confidence in the drug’s potential to fill a critical therapeutic gap.
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