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A phase 2 trial of CUE-221, a novel anti-IgE monoclonal antibody, showed that over half of patients with chronic spontaneous urticaria (CSU) achieved complete hives resolution at week 12 — beating both placebo and omalizumab. Notably, benefits persisted for 12 weeks after the last dose in the highest-dose group, suggesting a potential disease-modifying effect. Phase 2b/3 trials are now in the works.
A new contender in the chronic hives space is turning heads. Phase 2 topline data for CUE-221 — a humanized anti-IgE monoclonal antibody — showed that adults with moderate-to-severe chronic spontaneous urticaria (CSU) who received the highest dose (4 mg/kg) had a 54% rate of complete hives resolution at week 12, compared to just 11% on placebo and 41% on omalizumab (Xolair), the current standard of care.
What really sets CUE-221 apart is its staying power. Unlike omalizumab, whose benefits faded quickly after the last injection, the high-dose CUE-221 group maintained a 60% complete hives resolution rate at week 28 — a full 12 weeks off drug. Researchers believe this reflects CUE-221's unique dual mechanism: it not only blocks IgE from triggering allergic reactions (like omalizumab does), but also suppresses new IgE production by preserving binding to the CD23 receptor.
By the Numbers:
Why it matters: If confirmed in larger trials, CUE-221 could become the first disease-modifying therapy for CSU — offering durable remission rather than just symptom suppression. Cue Biopharma is now planning a phase 2b/3 study in CSU and a phase 2 study in food allergy.
