UCB hits the mark in bimekizumab psoriasis study

Big things keep happening at Belgium-based UCB. A little more than a week after announcing plans to acquire Ra Pharmaceutical for $2.1 billion, the company’s psoriasis drug bimekizumab hit the mark in the first of three Phase III studies. With 16 weeks of treatment, bimekizumab-treated patients saw a 90% improvement based on clinical assessment scales.

Bimekizumab, an IL-17A and IL-17F inhibitor, hit the co-primary endpoints of at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA 0/1) score of clear or almost clear in the late-stage BE VIVID trial. In addition to hitting its co-primary endpoints, bimekizumab also hit key secondary endpoints, including that it was found to be superior to ustekinumab (Janssen’s Stelara) in reaching PASI 90 and IGA 0/1 and superior to placebo in total skin clearance. Full details of the trial will be presented “in due course,” UCB said this morning.

Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. The skin condition affects men and women of all ages and ethnicities. Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales, dry, cracked skin that may bleed and thickened, pitted or ridged nails. Psoriasis impacts about 125 million people worldwide. Despite a number of available treatments, there are still unmet needs for patients. As UCB points to in its announcement, approximately 30% of psoriasis patients reported that their primary treatments do now keep their symptoms under control.

 IL-17A and IL-17F are two key cytokines driving inflammatory processes in medical issues such as psoriasis, as well as Crohn’s disease and others. Bimekizumab is also being evaluated in psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis.

Mark Lebwohl, lead study investigator and chairman of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, said the first of the three Phase III trials delivered “encouraging first results” He said the data provides strong evidence that bimekizumab has the “potential to raise the bar for achieving skin clearance rates for patients.” Clear skin, Lebwhohl said, is of critical importance in positively impacting the lives of psoriasis patients.

“Psoriasis affects all aspects of a patient’s life. We believe that bimekizumab has the potential to be a meaningful new treatment option for people living with psoriasis,” Iris Loew-Friedrich, head of drug development and chief medical officer at UCB said in a statement. “Today’s positive BE VIVID results are just the start. We look forward to sharing further findings from the bimekizumab clinical development program in the coming months.”

Last week, UCB announced plans to acquire Ra and its assets as a means to boost treatment options for people living with myasthenia gravis and other rare diseases. Ra’s Phase III zilucoplan achieved clinically meaningful and statistically significant reductions in both primary and key secondary endpoints in a late-stage trial at the end of 2018.