Phase 3 Data for Bimekizumab Shows Well Maintained Response

Bimekizumab (BimzeLX, UCB) reduced the abscess and inflammatory nodule count better than placebo in patients with hidradenitis suppurativa (HS), according to a late breaking session at the 2023 American Academy of Dermatology (AAD) Meeting in New Orleans, LA.¹

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The 2 randomized, double-blind, placebo-controlled phase 3 studies, called HEARD I and HEARD II, were designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe HS. The studies enrolled 1,014 patients (n=505 in BE HEARD I; n=509 in BE HEARD II) for 16-week initial and 32-week maintenance treatment periods and evaluated 2 dose regimens of bimezikumab (320 mg every two weeks [Q2W] and 320 mg every four weeks).

According to the data at AAD:

• A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved the Hidradenitis Suppurativa Clinical Response (HiSCR50), the primary endpoint, at week 16 vs. placebo in BE HEARD I and BE HEARD II (47.8 percent vs. 28.7 percent [p=0.006] and 52.0 percent vs. 32.2 percent [p=0.003], respectively).
• Patients treated with bimekizumab achieved deep levels of clinical response with a greater proportion achieving HiSCR75, a key secondary endpoint, at week 16 than placebo, with statistical significance in BE HEARD II with both dose regimens and for Q2W in BE HEARD I.
• Over 75% of patients achieved HiSCR50 and over 55% achieved HiSCR75 at week 48.

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. It 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). Currently, only adalimumab has FDA approval to treat HS.

UCB, a global biopharmaceutical company, first released data from the trials at 16 weeks in December 2022. It expects to submit global regulatory applications for bimekizumab in moderate to severe HS later this year. ²

References

1. Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicenter studies. Presented at Late-breaking Research Session 1 of the Annual Academy of Dermatology Annual Meeting. March 17-21, 2023; New Orleans, LA.

2. Bimekizumab phase 3 data in hidradenitis suppurativa show clinically meaningful, deep and maintained response over 48 weeks. UCBCOM. March 2023. https://www.ucb.com/stories-media/Press-Releases/article/Bimekizumab-Phase-3-Data-in-Hidradenitis-Suppurativa-Show-Clinically-Meaningful-Deep-and-Maintained-Response-over-48-Weeks. Accessed March 20, 2023.