Celldex Reports Topline Results From The Company’s Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Trials Evaluating Two Doses Of Barzolvolimab In Patients With Chronic Spontaneous Urticaria; Results Showed Rapid, Profound, Sustained Efficacy, Supporting Barzolvolimab’s Potential To Be A Transformational Therapy In CSU
EMBARQ-CSU1 and -CSU2 met primary and all key secondary endpoints at 12 weeks across both studies and both dose groups
Clinically meaningful and statistically significant benefit demonstrated in omalizumab refractory CSU and patients with severe disease or severe angioedema
Efficacy sustained or deepened from weeks 12 to 24
Well tolerated with a favorable safety profile through 24 weeks; consistent with prior studies
Treatment will continue in both trials to 52 weeks; BLA submission anticipated in 2027
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