UCB recently announced the positive results of the Phase 3 BE READY study, which evaluated the safety and efficacy of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis. These results come from the second of three Phase 3 studies to evaluate the IL-17A and IL-17F inhibitor bimekizumab vs placebo.
These data follow the positive clinical results recently reported from the Phase 3 BE VIVID study, which evaluated the safety and efficacy of bimekizumab vs placebo and ustekinumab, in adults with moderate-to-severe plaque psoriasis. The BE VIVID study met all primary and ranked secondary endpoints showed statistically significant superiority for bimekizumab treatment compared to placebo and ustekinumab in achieving skin clearance and disease improvement at week 16.
"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," Andrew Blauvelt, MD, MBA, Lead Study Investigator and President, Oregon Medical Research Center in Portland, Oregon, wrote in a press release. “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."
The 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 was met in the randomized withdrawal study.
Bimekizumab was statistically superior to placebo in achieving total skin clearance (PASI 100) at week 16, meeting a key secondary primary endpoint.
The study also found that 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 and was superior to placebo in achieving rapid response, defined as PASI 75 at week 4.
At 56 weeks, continued treatment with bimekizumab resulted in a statistically superior response compared to placebo, during the randomized withdrawal period of the study, according to the release.
The safety profile of bimekizumab was consistent with earlier clinical studies, according to the initial data assessment.
According to the press release, the full results of the BE READY study will be presented at a scientific congress in 2020.
"We are delighted to announce positive data on bimekizumab for the second time in just 4 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” Iris Loew-Friedrich, Head of Drug Development and Chief Medical Officer, UCB, said in the release. “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."
Disclosure: Loews Friedrich is an employee of UCB.