Celldex’s barzolvolimab meets primary endpoint in Phase 2 urticaria study

Celldex announced positive topline results from the company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria refractory to antihistamines, including patients who received prior biologics. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who do not respond to omalizumab. Data from the 208 patients randomized in the study showed that barzolvolimab achieved the primary efficacy endpoint, with a statistically significant mean change from baseline to week 12 of UAS7 – urticaria activity score – compared to placebo. Barzolvolimab demonstrated rapid, durable and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines. Barzolvolimab was generally well tolerated with a favorable safety profile. Most adverse events were mild to moderate in severity.