Bimekizumab meets endpoints in phase 3 hidradenitis suppurativa studies

Bimekizumab for the treatment of moderate to severe hidradenitis suppurativa met the primary endpoint and key secondary endpoint in two phase 3 studies, UCB announced in a press release.

The BE HEARD I and BE HEARD II randomized, double-blind, placebo-controlled, parallel-group, multicenter studies evaluated the safety and efficacy of bimekizumab, a humanized monoclonal IgG1 antibody designed to inhibit interleukins 17A and 17F.

For the primary endpoint, bimekizumab demonstrated statistically significant and clinically meaningful improvements over placebo in the proportion of subjects who achieved at least a 50% reduction from baseline in total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count, at week 16. For the secondary endpoint, bimekizumab demonstrated statistically significant improvements over placebo with at least a 75% reduction in total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count, at week 16.

The safety profile of bimekizumab was consistent with previous studies, and no new safety signals were observed.

“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,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S., UCB, said in the release.

The results will be used to support global regulatory license applications for bimekizumab in hidradenitis suppurativa in 2023.