UCB announced positive results from the Phase IIIb BE RADIANT study, a direct comparison of the investigational IL-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Cosentyx (secukinumab) in the treatment of adult patients with moderate-to-severe plaque psoriasis . BE RADIANT is the first head-to-head study comparing anti-IL-17 treatments, and the first study to demonstrate superiority to secukinumab for complete skin clearance at both weeks 16 and 48 .
BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating the superiority of bimekizumab over secukinumab for complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100). The BE RADIANT study also met all ranked secondary endpoints with statistical significance. Bimekizumab was superior to secukinumab in achieving PASI 75 at week 4 and complete skin clearance at week 48, with both monthly (Q4 week) and bi-monthly (Q8 week) dosing. The ongoing data assessment indicates that the safety profile of bimekizumab continues to be consistent with earlier clinical studies.
Bimekizumab has a robust Phase III psoriasis clinical development program. Detailed findings from the BE VIVID and BE READY studies were announced in June 2020 at the American Academy of Dermatology VMX, and the BE SURE results will be presented this year. The full BE RADIANT results will be presented to the scientific community in due course.
Bimekizumab’s safety and efficacy are also currently being evaluated in Phase III trials for potential indications in psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.
The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.