New Phase III data for hidradenitis suppurativa biologic released

UCB has announced positive results from the first Phase III trials evaluating the efficacy and safety of an IL-17A and IL–17F inhibitor to treat adults with moderate-to-severe hidradenitis suppurativa. Humanised IgG1 monoclonal antibody (mAb) BIMZELX^® (bimekizumab-bkzx) selectively binds to IL-17A, IL-17F, and IL-17AF cytokines. This inhibits their interaction with the IL-17RA/IL-17RC receptor complex, UCB explained.

The biologic enabled a “significantly higher” number of individuals to obtain a 50 percent or greater improvement in hidradenitis suppurativa signs and symptoms at Week 16, when compared to placebo, the results show.

Furthermore, bimekizumab facilitated clinically meaningful improvements in the ranked key secondary endpoint, HiSCR75 versus placebo at Week 16, UCB confirmed.

UCB explained that this endpoint is defined as “at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess and inflammatory nodule count or draining tunnel count”. Patient responses were maintained to Week 48, according to the data. 

Overall, “bimekizumab consistently demonstrated sustained improvements in clinical- as well as patient-reported outcomes for people with moderate to severe disease. These findings provide strong support for targeting IL-17A and IL-17F as a new and promising therapeutic approach for the future,” remarked lead investigator, Dr Alexa Kimball, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, US.

These data from the BE HEARD I and BE HEARD II clinical trials were published in The Lancet. UCB added that the two studies enrolled a combined total of 1,014 individuals with moderate-to-severe hidradenitis suppurativa.

Regulatory approvals of bimekizumab

“The positive results from these trials support global regulatory submissions for BIMZELX (bimekizumab) in this chronic inflammatory skin disease,” stated Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB.

UCB shared that last month the European Commission approved BIMZELX as a treatment for active moderate-to-severe hidradenitis suppurativa in adult patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

This medicine was authorised by the European Commission for plaque psoriasis in August 2021.