Celldex presents data from barzolvolimab Phase 1b study in CSU

Celldex Therapeutics announced updated data from the company’s Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria, or CSU, refractory to antihistamines. 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 the function and survival of the mast cell. 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. Meaningful symptom improvement as measured through the urticaria activity score over 7 days was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels, consistent with the profound and sustained reduction of tryptase associated in these groups. The data show that multiple doses of barzolvolimab resulted in rapid dose-dependent decreases in itch and hives with durable and prolonged symptom control. Importantly, administering multiple doses of barzolvolimab continues to demonstrate a favorable safety profile. Most adverse events were mild or moderate in severity and resolved while on study. Taken together with strong activity data, these data continue to support the ongoing Phase 2 clinical trials in chronic urticaria and expanded barzolvolimab development into other mast cell related indications.