Topline Results Announced for Second Phase 3 Trial of Bimekizumab

November 21, 2019
Mary Caffrey
Mary Caffrey

BE READY is designed to evaluate the safety and efficacy of bimekizumab, humanized monoclonal IgG1 antibody that targets and neutralizes interleukin- (IL-)17A and IL-17F, a pair of cytokines that propel the inflammatory process through their effects on other messengers in the body that trigger chronic inflammatory response.

UCB has announced results from BE READY, the second of 3 phase 3 studies to report findings on the investigational dual inhibitor bimekizumab for the treatment of adults with moderate-to-severe psoriasis.

According to a company statement released Friday, the randomized withdrawal study met its co-primary end points of at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessement (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared with placebo.

BE READY is designed to evaluate the safety and efficacy of bimekizumab, humanized monoclonal IgG1 antibody that targets and neutralizes interleukin- (IL-)7A and IL-17F, a pair of cytokines that propel the inflammatory process through their effects on other messengers in the body that trigger chronic inflammatory response. Bimekizumab is being studied for its effects on both plaque psoriasis and psoriatic arthritis, as well as akylosing spondylitis and non-radiographic axial spondyloarthritis.

The statement from UCB said the investigational therapy was statistically superior to placebo on key secondary end points, including total skin clearance (PASI 100) at week 16, and in patient-reported reductions in itch, pain, scaling, and clear or nearly clear scalp at week 16. The therapy was statistically superior to placebo in meeting rapid response, defined as PASI 75 by week 4. After week 16, continued treatment resulted in statistically superior response at week 56 during the randomized withdrawal period, according to the statement.

On safety, the statement says that bimekizumab was consistent with earlier clinical studies. Results from BE ABLE 1, a 12-week randomized trial published in the Journal of the American Academy of Dermatology, stated that treatment-emergent adverse events were reported by 126 of 208 (61%) of the bimekizumab-treated patients, compared with 15 of 42 (36%) of the placebo-treated patients.1

Full results will be presented at a scientific congress in 2020, and the company plans to submit the data to regulatory authorities in mid-2020.

Reference

Papp KA, Merola JF, Gottlieb AB, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10. doi: 10.1016/j.jaad.2018.03.037.