UCB’s bimekizumab, an IL-17A and IL-17F inhibitor, bested placebo and Stelara (ustekinumab) when it came to clearing the skin of patients with moderate-to-severe chronic plaque psoriasis and improving their symptoms, the company reports.
BE VIVID is the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate-to-severe chronic plaque psoriasis. UCB shares rose with the release of the new study data.
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).
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 2 studies.
"These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates for patients,” says Mark Lebwohl, M.D., Lead Study Investigator, Waldman Professor of Dermatology and Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, in a news release. “Achieving clear skin is of critical importance in positively impacting the lives of psoriasis patients. Today’s announcement marks an important milestone in the extensive clinical development of bimekizumab.”
He adds that “Bimekizumab represents a major breakthrough in both our understanding and treatment of psoriasis. We already have treatments that block IL17A and provide dramatic benefit for psoriasis patients but this drug blocks both IL-7A and IL-17F resulting in even greater improvements for patients.”
"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," says Iris Loew-Friedrich, Head of Drug Development and Chief Medical Officer, UCB. "Today’s positive BE VIVID results are just the start. We look forward to sharing further findings from the bimekizumab clinical development program in the coming months."
The safety and efficacy of bimekizumab is also being evaluated in psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.