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Celldex Therapeutics Announces Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria
-Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose
About this update from Celldex Therapeutics, Inc.
[{"type":"text","content":"-Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups--Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group--Barzolvolimab was generally well tolerated with a favorable safety profile--Treatment will continue to 52 weeks; results support further development of barzolvolimab in Phase 3 CSU studies-- Company to host webcast call today at 8:00 am ET- HAMPTON, N.J., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) 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. \"We are thrilled to share these positive results which we believe further establish barzolvolimab as a potential transformative treatment option for patients suffering with CSU,\" commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. \"These data reinforce barzolvolimab's unique mechanism targeting a key underlying pathway of the disease. Based on the strength of these results, which included patients refractory to omalizumab, we are excited to continue the development of this program and move towards registrational trials. We would like to thank the patients and investigators for their participation in this trial and look forward to presenting full 12 week data from this study at an upcoming medical meeting.” 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 demonstr...