- Celldex Therapeutics Inc CLDX announced updated data from its Phase 1b trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines.
- CSU is characterized by the occurrence of hives or wheals for six weeks or longer without identifiable specific triggers or causes.
- Meaningful symptom improvement, measured through the urticaria activity score over 7 days (UAS7), was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels.
- Related: Read How Cantor Views Celldex Therapeutics' Barzolvolimab Data.
- Mean UAS7 reduction at week 12 was 67% in the 1.5 mg/kg dose group (n=8), 67% in the 3.0 mg/kg dose group (n=9), and 82% in the 4.5 mg/kg dose group (n=9).
- Complete response as measured by UAS7=0 was 56% in patients treated with the 1.5 mg/kg, 3.0 mg/kg, and 4.5 mg/kg doses at week 12.
- At week 24, 16 weeks after the last dose, 53% of all patients treated with the 1.5 mg/kg and 3.0 mg/kg doses (additional follow-up ongoing in 4.5 mg/kg dose) had a complete response.
- Data exhibits that multiple doses of barzolvolimab resulted in rapid dose-dependent decreases in itch and hives with durable and prolonged symptom control.
- Rapid onset of responses after initial dosing and sustained durability were observed; onset as early as one week after the first dose and prolonged symptom control in some patients for up to 24 weeks.
- Tryptase suppression, indicative of mast cell depletion, paralleled symptom improvement, demonstrating the impact of mast cell depletion on CSU disease activity.
- Barzolvolimab was well tolerated with a favorable safety profile; the effects of multiple-dose administration were consistent with observations in single-dose studies.
- Price Action: CLDX shares are up 9.20% at $43.80 premarket on the last check Friday.
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