UCB reported Friday that the experimental drug bimekizumab, which targets both IL-17A and IL-17F, demonstrated superiority to Novartis' IL-17A inhibitor Cosentyx (secukinumab) for complete skin clearance at weeks 16 and 48 in a Phase IIIb study of adults with moderate-to-severe plaque psoriasis. "The BE RADIANT results demonstrate that bimekizumab has the potential to raise the treatment bar for patients and their dermatologists," remarked Emmanuel Caeymaex, executive vice president of immunology solutions at UCB.
The trial included 743 participants with psoriasis for at least six months prior to screening who were randomised to receive bimekizumab at one of two doses or Cosentyx for a 48-week treatment period, followed by a further 96-week extension period. The study's primary endpoint was achievement of 100% improvement on the Psoriasis Area and Severity Index (PASI 100) at week 16.
Along with hitting the main goal, UCB said that bimekizumab met all ranked secondary endpoints with statistical significance. Specifically, bimekizumab was superior to Cosentyx in achieving PASI 75 at week four and complete skin clearance at week 48, with both monthly and bi-monthly dosing. The drugmaker added that the ongoing data assessment indicates that the safety profile of bimekizumab "continues to be consistent" with earlier studies, adding that full results will be presented in the future.
Cosentyx and Stelara bested
Last month, UCB presented the first data from the Phase III development programme for bimekizumab, with results from the BE VIVID and BE READY studies showing that the drug achieved superior skin clearance compared to placebo or Johnson & Johnson's Stelara (ustekinumab) in adults with moderate-to-severe plaque psoriasis. At the time, Bernstein analysts suggested that bimekizumab will come to market in the second half of 2021, and could generate EU and US sales of €1.4 billion ($1.6 billion) in 2030.
UCB is also evaluating bimekizumab in Phase III trials for potential indications in psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa. For related analysis, read Physician Views: UCB's bimekizumab message set to resonate with dermatologists, and KOL Views Results: UCB faces real world hurdles despite bimekizumab’s big win on efficacy, says leading dermatologist.
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