Other Events ·
Cue Biopharma announced positive topline results from a Phase 2 clinical trial of CUE-221 in patients with…
CUECue Biopharma, Inc.
Cue Biopharma announced positive topline results from a Phase 2 clinical trial of CUE-221 in patients with moderate-to-severe chronic spontaneous urticaria (CSU). The study enrolled 145 participants and compared subcutaneous doses of CUE-221 against placebo and omalizumab. At week 12, the primary endpoint of complete hives resolution (HSS7=0) was met at all dose levels, with rates of 54% for 4 mg/kg, 53% for 2 mg/kg, and 43% for 1 mg/kg versus 11% for placebo. The key secondary endpoint of complete response (UAS7=0) achieved statistical significance only at the highest dose level (46% vs 11%). Efficacy persisted through week 28, with the 4 mg/kg group showing a statistically significant advantage over omalizumab (60% vs 24%) after treatment cessation. The drug demonstrated a favorable safety profile with no treatment-related serious adverse events or anaphylaxis. Based on these findings, the company plans to initiate a Phase 2b/3 trial in CSU and a Phase 2 trial in food allergy. Cue Biopharma is a clinical-stage biopharmaceutical company developing transformative therapies for immune-mediated diseases.