The positive results from these studies will form the basis of global regulatory license applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023. 

UCB’s bimekizumab may be a promising treatment approach in adults with moderate to severe hidradenitis suppurativa, according to topline results from two Phase 3 studies, BE HEARD I and BE HEARD II.

The positive results from these two studies will form the basis of global regulatory license applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023. 

Bimekizumab is an investigational product; its efficacy and safety have not been established for any indication in the U.S., and it is not approved by the U.S. Food and Drug Administration (FDA).

“We are excited to announce positive pivotal Phase 3 outcomes in moderate to severe hidradenitis suppurativa which support our strong belief in bimekizumab and provide the first Phase 3 evidence suggesting that targeting IL-17F in addition to IL-17A may be a promising treatment approach. We look forward to bringing bimekizumab to people living with this chronic inflammatory disease as soon as possible,” says Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB, in a news release.

Across the two studies, bimekizumab met the primary endpoint, demonstrating statistically significant and consistent clinically meaningful improvements over placebo in the proportion of patients who achieved the Hidradenitis Suppurativa Clinical Response (HiSCR50) at week 16. Bimekizumab demonstrated depth of response with statistically significant improvements at week 16 over placebo in the percentage of patients achieving HiSCR75, a key secondary endpoint in both studies. HiSCR50 and HiSCR75 are 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 or draining tunnel count. The safety profile of bimekizumab in both studies was consistent with previously reported studies with no new observed safety signals.

“Hidradenitis suppurativa is a chronic, painful and debilitating inflammatory skin disease that impacts patients’ physical, psychological, and social well-being. This reduced quality of life is compounded by the limited treatment options currently available,” says Professor Gregor Jemec, MD, Ph.D., Chairman, Department of Dermatology Zeeland University, Roskilde, Denmark. “The positive top-line clinical outcomes from BE HEARD I and BE HEARD II are promising and demonstrate the value that bimekizumab can potentially bring to the hidradenitis suppurativa community.”

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.

About BE HEARD I

BE HEARD I is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa. BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe hidradenitis suppurativa. For additional details on the study, visit BE HEARD I on clinicaltrials.gov.

About BE HEARD II

BE HEARD II is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa. BE HEARD II enrolled 509 participants with a diagnosis of moderate to severe hidradenitis suppurativa.4 For additional details on the study, visit BE HEARD II on clinicaltrials.gov.