Celldex reports Phase 3 CSU trial results
- Celldex Therapeutics (NASDAQ:CLDX) reported positive Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 results for barzolvolimab in chronic spontaneous urticaria.
- Both trials met their primary endpoint, showing greater reductions in weekly urticaria activity scores compared with placebo at Week 12.
- Celldex stated that it plans to submit a Biologics License Application for barzolvolimab in 2027.
Celldex Therapeutics (NASDAQ:CLDX) reported positive topline results from two Phase 3 trials evaluating barzolvolimab in adults with chronic spontaneous urticaria.
The EMBARQ-CSU1 and EMBARQ-CSU2 studies met the primary endpoint, with barzolvolimab showing greater reductions in weekly urticaria activity scores at Week 12 compared with placebo.
The trials also met all key secondary endpoints, including complete response rates at Week 24, where the 150 mg dose achieved 49%–54% response rates compared with 15.4%–17.6% for placebo.
Barzolvolimab was evaluated in randomized, double-blind, placebo-controlled studies involving patients with chronic spontaneous urticaria, including those who had not responded adequately to omalizumab.
The company reported that complete response rates in omalizumab-refractory CSU patients at Week 12 ranged from 41.7%–55.3% for barzolvolimab compared with 9.3%–15.1% for placebo.
Celldex is developing barzolvolimab as an antibody therapy targeting mast cells, which are involved in allergic and inflammatory responses, and the company plans a Biologics License Application submission in 2027.
