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Bimekizumab Phase III study meets all endpoints

UCB has announced positive results from BE VIVID, the first of three Phase III studies evaluating the efficacy and safety of 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% 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 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.

These encouraging first results provide strong evidence that bimekizumab has the potential to raise the bar for achieving skin clearance rates for patients. 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,” said Mark Lebwohl, MD, 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.

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,” said 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.

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