Cue Biopharma (NASDAQ:CUE) on Sunday shared topline results from a Phase 2 trial of CUE-221 in patients with moderate to severe chronic spontaneous urticaria.
The study met its primary and secondary endpoints, demonstrating sustained efficacy and a favorable safety profile.
Cue Biopharma shares initially traded higher Monday before pulling back and turning negative.
Phase 2 Study Design And Key Endpoints
Genesis Life Sciences conducted the trial in China, enrolling 145 patients whose chronic hives were inadequately controlled by H1 antihistamines.
The study evaluated subcutaneous CUE-221 at doses of 4 mg/kg, 2 mg/kg, and 1 mg/kg administered every four weeks against placebo and active comparator omalizumab.
At Week 12, CUE-221 met its primary endpoint of complete hive resolution across all dose levels.
Specifically, 54% of patients receiving the 4 mg/kg dose attained complete resolution compared to 11% for placebo.
The 4 mg/kg group also met the key secondary endpoint, achieving a statistically significant 46% complete response rate at Week 12.
Long-Term Response And Phase 2b/3 Plans
Peak effect occurred at Week 22, with 69% of patients in the 4 mg/kg group exhibiting complete resolution.
Following final dosing at Week 16, benefits lasted through Week 28.
At Week 28, 12 weeks off drug, CUE-221 demonstrated a statistically significant 36% efficacy advantage over omalizumab.
Shao-Lee Lin, President and CEO of Cue Biopharma, highlighted that CUE-221 represents a potential best therapeutic option.
Lin stated the company is preparing to initiate a Phase 2b/3 trial in chronic hives while advancing a Phase 2 study in food allergy.
The candidate demonstrated a favorable safety profile with no treatment-related serious adverse events or anaphylaxis.
CUE Price Action: Cue Biopharma shares were down 28.53% to $26.48 at the time of publication on Monday, according to Benzinga Pro data.
Image via Shutterstock