other material
confidence high
sentiment positive
materiality 0.75
Celldex reports 100% clinical response rate and 95% complete response for CDX-0159 in Phase 1b inducible urticaria
Celldex Therapeutics, Inc.
- 19 of 19 patients (100%) showed clinical response; 18 of 19 (95%) achieved complete response by provocation testing.
- Rapid onset: complete responses by week 1 (cold urticaria) and week 4 (symptomatic dermographism); median duration 77+ and 57+ days.
- Single 3 mg/kg dose suppressed serum tryptase and depleted skin mast cells (87% depletion); well tolerated with mild reversible adverse events.
- Subcutaneous formulation enters clinic Q3 2021; Phase 2 urticaria studies start H1 2022; prurigo nodularis study Q4 2021.