Celldex Therapeutics Inc (NASDAQ: 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.
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.
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