UCB has announced that the Phase III BE VIVID clinical trial of its bimekizumab met all primary and key secondary endpoints in moderate-to-severe chronic plaque psoriasis patients.
Psoriasis is a common inflammatory disease that affects nearly 125 million people globally.
Bimekizumab is an investigational humanised monoclonal IgG1 antibody and selective inhibitor of IL-17A and IL-17F cytokines, which are known to be associated with chronic inflammation and tissue damage.
The BE VIVID trial evaluated the safety and efficacy of the drug in 570 participants suffering from chronic plaque psoriasis for a minimum of six months before their screening.
This is the first trial in a series of three Phase III studies assessing the drug for moderate-to-severe chronic plaque psoriasis treatment in adults.
The trial’s co-primary endpoints were the proportion of patients experiencing 90% improvement in the Psoriasis Area and Severity Index (PASI) score and Investigator Global Assessment (IGA) response at week 16.
Bimekizumab met both endpoints according to the study data.
For key secondary endpoints, the drug showed superiority to ustekinumab in achieving PASI 90 and IGA 0/1, and superiority to placebo in total skin clearance (PASI 100 or IGA 0) at week 16.
Initial analysis found bimekizumab’s safety profile to be consistent with the previous BE ABLE Phase II trials.
UCB chief medical officer and drug development head Iris Loew-Friedrich said: “Psoriasis affects all aspects of a patient’s life. We believe that bimekizumab has the potential to be a meaningful new treatment option for people living with psoriasis.
“Today’s positive BE VIVID results are just the start. We look forward to sharing further findings from the bimekizumab clinical development programme in the coming months.”
Apart from plaque psoriasis, bimekizumab is being developed to treat psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).