Celldex's Barzolvolimab Shows Rapid, Durable Responses In Early Urticaria Study

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  • Celldex Therapeutics Inc CLDX announced interim data from Phase 1b trial of barzolvolimab in chronic spontaneous urticaria (CSU) refractory to antihistamines. 
  • CSU is characterized by the occurrence of hives or weals for six weeks or longer without identifiable specific triggers or causes.
  • Data show that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, with a mean UAS7 reduction of 66.6% in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in 3.0 mg/kg dose group (n=9) at week 8, demonstrating meaningful symptom improvements for patients. 
  • Complete response was 57.1% for the 1.5 mg/kg dose group and 44.4% for 3.0 mg/kg dose group.
  • Barzolvolimab demonstrated a favorable safety profile, supporting Phase 2 clinical development.
  • The Phase 1b study is expected to enroll approximately 40 patients with CSU across four cohorts, either alone or in combination with H2-antihistamines and/or leukotriene receptor agonists. 
  • Price Action: CLDX shares are down 14.95% at $22.93 during the market session on the last check Friday.
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