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UCB, a global biopharmaceutical company, announced positive top-line results from two phase 3 studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa.
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. The safety and efficacy of bimekizumab in hidradenitis suppurativa have not been established, and it is not approved for use in hidradenitis suppurativa by any regulatory authority worldwide.
“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,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.
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 per cent 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,” said 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.
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.
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.
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease. The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin) which typically occur in the armpits, groin and buttocks. People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.
HS develops in early adulthood, affects approximately one percent of the population in most studied countries and is three times more common in women than in men. Approximately one third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS.
The symptoms of pain, discharge and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms. These feelings can lead to embarrassment, social isolation, low self-esteem and sexual life impairment, and impact all areas of life, including interpersonal relationships, education and work.
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.
In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The label information may differ in other countries.
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system.
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