Cue Biopharma Announces Positive Phase 2 Results for CUE‑221 in Chronic Spontaneous Urticaria
Cue Biopharma (NASDAQ:CUE) disclosed topline data from a multicenter, randomized, double‑blind Phase 2 trial of its investigational antibody CUE‑221 in patients with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by H1 antihistamines. The study was conducted in China by Genesis Life Sciences, a related company of Ascendant Health Limited, and enrolled 145 participants.
The trial comprised a 16‑week treatment period followed by a 20‑week post‑treatment follow‑up. Participants were randomized to one of five arms: CUE‑221 at 4 mg/kg, 2 mg/kg, or 1 mg/kg administered every four weeks; placebo every four weeks; or omalizumab 300 mg every four weeks.
Efficacy
- The primary endpoint, proportion of patients achieving a HSS7 score of 0 at week 12, was met with statistical significance at all CUE‑221 dose levels. The 4 mg/kg dose produced a 54 % complete hive‑resolution rate, compared with 11 % for placebo and 41 % for omalizumab.
- The key secondary endpoint, proportion achieving a UAS7 score of 0 at week 12, was also statistically significant for the 4 mg/kg dose, with 46 % of patients responding versus 11 % on placebo and 29 % on omalizumab.
- Response rates continued to improve beyond week 12, peaking at week 22 across all CUE‑221 dose groups. At week 28 (12 weeks after the final dose), the 4 mg/kg cohort maintained a 60 % complete‑resolution rate, markedly higher than the 24 % observed with omalizumab.
Safety
- CUE‑221 demonstrated a favorable safety profile; there were no treatment‑related serious adverse events and no cases of hypersensitivity reactions, including anaphylaxis.
Next Steps
- Cue Biopharma plans to launch a combined Phase 2b/3 study in CSU and a separate Phase 2 study in food allergy.
- The company will host a conference call on Monday at 8:00 a.m. EDT to present the full results.