Cue Biopharma's Anti-IgE Antibody CUE-221 Meets Phase 2 Endpoints in Chronic Spontaneous Urticaria: 54% Complete Hive Resolution at Week 12 vs 11% on Placebo
Cue Biopharma announced on Sunday, September 20, 2026 topline results from a Phase 2 trial in China of CUE-221, a humanized anti-IgE IgG1 monoclonal antibody that the company says also reduces IgE synthesis, in 145 patients with moderate-to-severe chronic spontaneous urticaria. Patients were randomized to one of three CUE-221 doses, placebo, or omalizumab 300 mg every four weeks. At week 12, complete hive resolution (HSS7 of 0) was reached by 54%, 53%, and 43% of patients on the 4, 2, and 1 mg/kg doses, versus 11% on placebo and 41% on omalizumab. There were no treatment-related serious adverse events and no hypersensitivity reactions. Cue, which licensed CUE-221 from Ascendant Health, plans a Phase 2b/3 study in chronic spontaneous urticaria and a Phase 2 study in food allergy.