• The Phase 3 BE READY study, evaluating the efficacy and safety of bimekizumab versus placebo in adults with moderate-to-severe chronic plaque psoriasis, met all primary and ranked secondary endpoints • UCB plans to submit applications to regulatory authorities for approval of bimekizumab to treat adults with moderate-to-severe plaque psoriasis in mid-2020
Brussels, Belgium – 15th November 2019, 7:00 AM CET – Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced positive results from BE READY, the second of three Phase 3 studies this year to report findings on the investigational treatment bimekizumab. BE READY evaluated the efficacy and safety of the IL-17A and IL-17F inhibitor bimekizumab in the treatment of adults with 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. 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.
These data follow the positive clinical results recently reported from the Phase 3 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.
“The bimekizumab Phase 3 development program continues to deliver impressive results, with BE READY being the second study to show strong and consistent outcomes with this drug. Psoriasis places a heavy burden on patients, often causing pain, discomfort and stigma. Clinical trial results with bimekizumab continue to show both robust skin clearance rates as well as improvements in itch, pain and scaling – critically important elements for people living with this disease,” said Andrew Blauvelt, M.D., M.B.A., Lead Study Investigator and President, Oregon Medical Research Center in Portland, Oregon.
“We are delighted to announce positive data on bimekizumab for the second time in just four weeks. UCB is now preparing for a bimekizumab submission to regulatory authorities in mid-2020 to bring this promising treatment option to people living with psoriasis. With the ongoing success of our clinical program for bimekizumab, UCB continues to deliver on its Patient Value Strategy to connect the unmet needs of patients with innovative science,” said Iris Loew-Friedrich, Head of Drug Development and Chief Medical Officer, UCB.
The safety and efficacy of bimekizumab are also being evaluated in psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).