First‐in‐human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL‐17A and IL‐17F, in mild psoriasis

• DOI: 10.1111/bcp.13185
• Publication Date: 2016-11-14T18:02:58Z
• Authors: Sophie Glatt; Eric Helmer; Birgit Haier; Foteini Strimenop...; Graham Price; Pavan Vajjah; Olivier A. Harari; John Lambert; Stevan Shaw
• Keywords: Tolerability; Clinical endpoint

Aims To assess safety, pharmacokinetics (PK) and clinical efficacy of bimekizumab (formerly UCB4940), a novel humanized monoclonal antibody dual inhibitor interleukin (IL)‐17A IL‐17F, in subjects with mild plaque psoriasis. Methods Randomized, double‐blind, first‐in‐human study 39 who received single‐dose intravenous (8–640 mg) or placebo (NCT02529956). Results Bimekizumab demonstrated dose‐proportional linear PK was tolerated across the dose range assessed. No subject discontinued due to treatment‐emergent adverse events no severe were reported. fast onset clinically‐meaningful effects on skin patients psoriasis as early Week 2. Maximal improvements (100% near 100% reductions from baseline) all measures disease activity observed between Weeks 8–12 receiving 160–640 mg bimekizumab. The duration effect at doses ≥160 evident up 12–20 after single dose, dependent endpoint. Conclusions This is first demonstrate tolerability IL‐17A IL‐17F inhibitor, showed by 2, maximal near‐maximal magnitude response that maintained 12–20. These findings support continued development for diseases mediated both including