Phase III BE READY study of UCB 4940 met primary endpoints in plaque psoriasis.- UCB

UCB announced positive results from BE READY, the second of three Phase III studies this year to report findings on the investigational treatment UCB 4940 (bimekizumab) in moderate-to-severe plaque psoriasis. This randomized withdrawal study met its co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Among key secondary endpoints, bimekizumab was statistically superior to placebo in achieving total skin clearance (PASI 100) at week 16.1

In addition, bimekizumab was statistically superior to placebo in patient-reported reductions in itch, pain and scaling, as well as clear or almost clear scalp (scalp IGA), at week 16. Bimekizumab was also statistically superior to placebo in achieving rapid response, defined as PASI 75 at week 4. Furthermore, after an initial week-16 response, continued treatment with bimekizumab resulted in a statistically superior response at week 56 compared to placebo, during the randomized withdrawal period of the study. The initial data assessment indicates that the safety profile of bimekizumab was consistent with earlier clinical studies. The full BE READY results will be presented at a scientific congress in 2020.

Comment: These data follow the positive clinical results recently reported from the Phase III BE VIVID study, evaluating the efficacy and safety of bimekizumab versus placebo and ustekinumab, in adults with moderate-to-severe plaque psoriasis. The study met all primary and ranked secondary endpoints, with bimekizumab showing statistically significant superiority to placebo and ustekinumab in achieving skin clearance and disease improvement at week 16. The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.