Phase III BE HEARD I and II studies of Bimzelx meet primary endpoint in Hidradenitis Suppurativa.- UCB

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 FDA.

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. 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.