- Top-line results show that the two Phase 3 studies, BE HEARD I and BE HEARD II, met their primary and key secondary endpoints with statistical significance and consistent clinical relevance
- First Phase 3 evidence to suggest that targeting IL-17F in addition to IL-17A may be a promising treatment approach in adults with moderate to severe hidradenitis suppurativa
- Results from these two studies will form the basis of global regulatory applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023
BRUSSELS, Belgium and ATLANTA, GA, USA I December 9, 2022 I UCB, a global biopharmaceutical company, today 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.1,2 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 U.S. Food and Drug Administration (FDA).
“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 U.S., 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 16.1,2 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.1,2 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.3,4 The safety profile of bimekizumab in both studies was consistent with previously reported studies with no new observed safety signals.1,2
“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.
Notes to editors:
About BE HEARD I
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.3 BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe hidradenitis suppurativa.3 For additional details on the study, visit BE HEARD I on clinicaltrials.gov.3
About BE HEARD II
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.4 BE HEARD II enrolled 509 participants with a diagnosis of moderate to severe hidradenitis suppurativa.4 For additional details on the study, visit BE HEARD II on clinicaltrials.gov.4
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.5,6 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.5,6 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.5,6
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.5,6 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.7
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.8 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.5,7
About bimekizumab
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.9
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.10,11 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 U.S. Food and Drug Administration (FDA).
About UCB
UCB, Brussels, Belgium (www.ucb.com) 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. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
References
- BE HEARD I Phase 3 Study, UCB Data on file, December 2022.
- BE HEARD II Phase 3 Study, UCB Data on file, December 2022.
- ClinicalTrials.gov. A study to test the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242446. Last accessed: December 2022.
- ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT04242498. Last accessed: December 2022.
- Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
- Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1);18
- Kokolakis G, Wolk K, Schneider-Burrus S et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–430.
- Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol 2019:12:785–790.
- Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
- BIMZELX® (bimekizumab) EU Summary of Product Characteristics, May 2022.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022.
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics, May 2022.
https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: December 2022.
US-N-BK-HS-2200005
Date of preparation: December 2022
SOURCE: UCB
Post Views: 81
- Top-line results show that the two Phase 3 studies, BE HEARD I and BE HEARD II, met their primary and key secondary endpoints with statistical significance and consistent clinical relevance
- First Phase 3 evidence to suggest that targeting IL-17F in addition to IL-17A may be a promising treatment approach in adults with moderate to severe hidradenitis suppurativa
- Results from these two studies will form the basis of global regulatory applications for bimekizumab in hidradenitis suppurativa starting in Q3 2023
BRUSSELS, Belgium and ATLANTA, GA, USA I December 9, 2022 I UCB, a global biopharmaceutical company, today 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.1,2 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 U.S. Food and Drug Administration (FDA).
“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 U.S., 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 16.1,2 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.1,2 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.3,4 The safety profile of bimekizumab in both studies was consistent with previously reported studies with no new observed safety signals.1,2
“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.
Notes to editors:
About BE HEARD I
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.3 BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe hidradenitis suppurativa.3 For additional details on the study, visit BE HEARD I on clinicaltrials.gov.3
About BE HEARD II
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.4 BE HEARD II enrolled 509 participants with a diagnosis of moderate to severe hidradenitis suppurativa.4 For additional details on the study, visit BE HEARD II on clinicaltrials.gov.4
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.5,6 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.5,6 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.5,6
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.5,6 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.7
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.8 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.5,7
About bimekizumab
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.9
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.10,11 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 U.S. Food and Drug Administration (FDA).
About UCB
UCB, Brussels, Belgium (www.ucb.com) 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. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
References
- BE HEARD I Phase 3 Study, UCB Data on file, December 2022.
- BE HEARD II Phase 3 Study, UCB Data on file, December 2022.
- ClinicalTrials.gov. A study to test the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242446. Last accessed: December 2022.
- ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT04242498. Last accessed: December 2022.
- Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
- Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6(1);18
- Kokolakis G, Wolk K, Schneider-Burrus S et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236(5):421–430.
- Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol 2019:12:785–790.
- Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.
- BIMZELX® (bimekizumab) EU Summary of Product Characteristics, May 2022.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022.
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics, May 2022.
https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833. Last accessed: December 2022.
US-N-BK-HS-2200005
Date of preparation: December 2022
SOURCE: UCB
Post Views: 81
