Cue Biopharma Announces Positive Topline Results from CUE-221 Phase 2 Study in Chronic Spontaneous Urticaria (GlobeNewswire) - Sep 20, 2026 - "The trial enrolled 145 participants with moderate to severe chronic spontaneous urticaria (CSU), a disease resulting in chronic hives, that remained inadequately controlled despite treatment with H1 antihistamines...The primary endpoint of percentage of patients with HSS7=0 at week 12 was dose-responsive and met at all dose levels. The key secondary endpoint of percentage of patients with UAS7=0 at week 12 was dose responsive and met statistical significance at the 4 mg/kg highest dose level...The percentage of participants who achieved HSS7=0 further increased beyond the Week 12 primary endpoint, peaking at Week 22 across all CUE-221 dose groups. After a last dose was administered for all groups at Week 16, clinically meaningful benefit was maintained for up to 12 weeks off treatment (through week 28) at the 4 mg/kg dose level."
P2 data • Chronic Spontaneous Urticaria
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