This is the first phase 3 evidence to suggest the drug as a promising treatment approach in adult patients.
UCB-USA, a global biopharmaceutical company, has announced positive top-line results from two phase 3 studies, assessing the safety and efficacy of bimekizumab (Bimzelx, UCB) in adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1
BE HEARD I and BE HEARD II were randomized, double-blind, placebo-controlled, parallel group, multicenter studies. BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe hidradenitis suppurative and BE HEARD II enrolled 509 patients with the same diagnosis. Both phase 3 studies showed that bimekizumab met the primary endpoint, demonstrating significant improvements over placebo in the patients who achieved the Hidradenitis Suppurativa Clinical Response (HiSCR50) at week 16, as well as showing statistically significant improvements at week 16 over placebo in patients achieving HiSCR75, a key secondary endpoint in both studies. HiSCR50 and HiSCR75 are defined as at least a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.
HS develops in early adulthood, and is a chronic, recurring, painful, and debilitating inflammatory skin disease that presents on the skin as nodules, abscesses and pus-discharging fistulas which appear typically in the armpits, groin, or buttocks.
UCB added that the safety profile of bimekizumab in both trials was consistent with previously reported studies with no new safety signals. Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the US., and it is not yet approved by the US Food and Drug Administration (FDA). Detailed results from BE HEARD I and BE HEARD II will be presented at an upcoming scientific meeting and published in a peer-reviewed medical journal.
1. UCB Announces Positive Phase 3 Studies for Bimekizumab in Hidradenitis Suppurativa. News Release. UCB. Published December 9, 2022. Accessed December 9, 2022. https://www.ucb-usa.com/stories-media/UCB-U-S-News/detail/article/ucb-announces-positive-phase-3-studies-for-bimekizumab-in-hidradenitis-suppurativa