BE VIVID phase III study of UCB 4940 meets co-primary endpoints in chronic plaque psoriasis.- UCB

UCB announced positive results from BE VIVID, the first of three Phase III studies evaluating the efficacy and safety of UCB 4940 (bimekizumab), an IL-17A and IL-17F inhibitor, in the treatment of adults with moderate-to-severe chronic plaque psoriasis. Results showed that after 16 weeks of treatment, bimekizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1). The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves 90 percent improvement from baseline in the PASI score) at Week 16, and IGA response (defined as clear or almost clear with at least a 2-category improvement relative to baseline) at Week 16.

Among key secondary endpoints, bimekizumab was also found to be superior to ustekinumab in reaching PASI 90 and IGA 0/1 and superior to placebo in total skin clearance (PASI 100 or IGA 0) at Week 16. The initial assessment indicates that the safety profile of bimekizumab was consistent with the earlier BE ABLE Phase II studies. The safety and efficacy of bimekizumab has not been established and it is not approved by any regulatory authority worldwide. The full BE VIVID results will be presented in due course.

Comment: Bimekizumab is an investigational humanized monoclonal IgG1 antibody that potently and selectively neutralizes IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have similar pro-inflammatory functions and independently synergize with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.