UCB Publishes Phase 3 BIMZELX® Trials for Moderate-to-Severe Hidradenitis Suppurativa in The Lancet

In a recent announcement, UCB, a global biopharmaceutical company, shared a significant advancement in the treatment of moderate-to-severe hidradenitis suppurativa (HS), a chronic skin disease. The results, published in The Lancet, highlight the Phase 3 BE HEARD I and BE HEARD II trials, which evaluate the efficacy and safety of BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor.

HS is a debilitating inflammatory condition characterized by painful skin lesions, nodules, abscesses, and pus-discharging fistulas, mainly affecting areas such as the armpits, groin, and buttocks. It significantly impacts the quality of life of those afflicted, causing pain, social stigma, and emotional distress.

Emmanuel Caeymaex, UCB's Executive Vice President and Chief Commercial Officer, emphasized the importance of these trials. He noted that the publication in a leading medical journal underscores the trials' significance to the dermatology community. The positive outcomes from these studies are pivotal for global regulatory submissions for BIMZELX in treating this chronic condition.

Lead Investigator Alexa B. Kimball from Harvard Medical School remarked on the significance of the Phase 3 trials. She highlighted the inclusion of HiSCR75, a stringent endpoint, as a key secondary outcome, demonstrating the drug's sustained improvements in both clinical and patient-reported outcomes.

UCB reported that the U.S. Food and Drug Administration (FDA) has accepted the review of the supplemental biologics license application for BIMZELX for treating adults with moderate-to-severe HS. Additionally, the European Commission has granted marketing authorization for BIMZELX for the same indication. Other regulatory submissions are in progress globally.

The BE HEARD I and BE HEARD II trials were randomized, double-blind, placebo-controlled, multicenter studies involving 1,014 participants diagnosed with moderate-to-severe HS. The primary endpoint was achieving HiSCR50 at Week 16, representing a 50 percent reduction in the total abscess and inflammatory nodule count. A key secondary endpoint was HiSCR75 at Week 16, indicating a 75 percent reduction. The trials revealed that a significant proportion of patients treated with bimekizumab achieved the primary endpoint of HiSCR50, and the key secondary endpoint of HiSCR75, compared to placebo. These responses were maintained up to Week 48, with the safety profile of bimekizumab remaining consistent with previous trials.

Bimekizumab is a humanized IgG1 monoclonal antibody that selectively targets IL-17A, IL-17F, and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex. In the U.S., BIMZELX is approved for treating moderate-to-severe plaque psoriasis in adults but is not yet approved for HS, and its efficacy and safety for HS remain investigational.

HS typically develops in early adulthood and affects around one percent of the population in many countries. A significant portion of those affected has a family history of HS, with lifestyle factors like smoking and obesity playing crucial roles in its clinical course. The condition’s symptoms and the associated stigma can lead to social isolation, low self-esteem, and impaired quality of life.

This breakthrough with BIMZELX holds promise for improving the lives of those suffering from HS, addressing both the physical and emotional burdens of the disease. UCB's ongoing efforts to seek regulatory approvals worldwide further underscore the potential impact of this treatment in providing much-needed relief to patients.