Peptide News Digest

#Csu

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Clinical Trials · View digest

Celldex Therapeutics Barzolvolimab (Anti-KIT Monoclonal Antibody) Meets Primary and All Key Secondary Endpoints in Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Trials in Chronic Spontaneous Urticaria

Celldex Therapeutics reported on Tuesday, September 22, 2026 that both Phase 3 trials of barzolvolimab, a humanized monoclonal antibody that binds the KIT receptor on mast cells, met their primary endpoint of mean change in weekly urticaria activity score (UAS7) at week 12 in adults with chronic spontaneous urticaria who remained symptomatic on H1 antihistamines. EMBARQ-CSU1 randomized 963 patients and EMBARQ-CSU2 randomized 976, for 1,939 in total. UAS7 fell by 19.7 to 20.5 points on the two barzolvolimab regimens (150 mg every 4 weeks or 300 mg every 8 weeks) versus 10.7 and 11.4 points on placebo, and complete response (UAS7 of 0) rates were 42.1% to 45.7% versus 9.3% and 12.6% on placebo. All key secondary endpoints were met, benefit was reported in omalizumab-refractory patients, and the drug was well tolerated through 24 weeks. Treatment continues to 52 weeks, and Celldex plans to file a Biologics License Application in 2027.

Clinical Trials · View digest

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.