Barzolvolimab Demonstrates Rapid Symptom Control in Phase 1b Trial
New research published in the European Journal of Allergy and Clinical Immunology reveals barzolvolimab (CDX-0159), a first-in-class monoclonal antibody, achieved rapid and sustained symptom relief in patients with antihistamine-resistant chronic spontaneous urticaria (CSU).
Study Design and Participant Profile
The phase 1b double-blind, randomized trial (NCT04538794) evaluated 42 adults with moderate-to-severe CSU who had failed antihistamine therapy. Participants received either barzolvolimab or placebo on two dosing schedules (every 4 or 8 weeks) across a 24-week study period.
The treatment groups showed balanced demographics:
- Median age: 49.3 years
- 80% female participants
- Disease duration ranging from 0.6 to >60 years
Key Efficacy Findings
Barzolvolimab demonstrated:
- 90% reduction in serum tryptase levels within days (1.5 mg/kg+ doses)
- 30-35 point UAS7 score reductions in higher dose groups (3.0-4.5 mg/kg)
- 60% of 4.5 mg/kg patients achieved near-complete symptom control (UAS7<6)
- Sustained effects throughout 12-week dosing period
Placebo recipients showed minimal symptom improvement, with none achieving full disease control.
Safety Profile
The treatment was well-tolerated with:
- Primarily mild-to-moderate adverse events
- No cumulative toxicity observed
- No dose-dependent safety concerns
Clinical Implications
“For severe CSU patients, symptom control remains challenging with current therapies,” researchers noted. “Barzolvolimab emerges as a promising novel treatment option.”
While limited by small sample size and prior medication variability, the findings support further investigation. Larger trials are currently underway to evaluate barzolvolimab’s potential across chronic urticaria subtypes.
Mechanistic Background
Barzolvolimab targets KIT receptors to:
- Reduce mast cell activity
- Lower tryptase levels
- Modulate inflammatory pathways
Previous 2023 research in Allergy journal demonstrated similar benefits for chronic inducible urticaria, establishing proof-of-concept for this novel mechanism.
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