Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful, Deep and Maintained Response over 48 Weeks
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- Patients treated with investigational bimekizumab, an IL-17A and IL-17F inhibitor, achieved statistically significant and clinically meaningful improvements over placebo in signs and symptoms of hidradenitis suppurativa at week 16, as measured by HiSCR50
- Bimekizumab demonstrated deep levels of clinical response over placebo at week 16, as measured by HiSCR75, a key secondary endpoint
- Patients treated with bimekizumab experienced improved health-related quality of life over placebo at week 16, a key secondary endpoint
- Clinical responses were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75, at week 48±
BRUSSELS and ATLANTA, March 18, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced detailed positive results from two Phase 3 studies (BE HEARD I and BE HEARD II) evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48.1,± Clinical responses with bimekizumab were observed from the first dose with some patients achieving HiSCR50 at week four.1 These new data were presented today at a late-breaking platform presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, March 17-22.
"Hidradenitis suppurativa is a chronic, debilitating inflammatory skin disease for which only one approved treatment is available today," said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston. "Treating moderate to severe cases with bimekizumab has shown promising results in Phase 3 patient trials, with sustained improvement after one year."
In the U.S., the efficacy and safety of bimekizumab have not been established for any indication, and it is not approved by the U.S. Food and Drug Administration.
The two studies (n=505 in BE HEARD I; n=509 in BE HEARD II) evaluated two dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 mg every four weeks
[Q4W]) versus placebo over the 16-week initial and the 32-week maintenance treatment periods.1 Data presented at AAD 2023 show that:
- A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved 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).1
- A greater proportion of patients treated with bimekizumab (Q4W) achieved HiSCR50 at week 16 than placebo in BE HEARD I and BE HEARD II, with statistical significance achieved in BE HEARD II (45.3 percent vs. 28.7 percent [p=0.030] and 53.8 percent vs. 32.2 percent [p=0.004], respectively).1
- 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.1
- Patients treated with bimekizumab experienced improved health-related quality of life (change from baseline in the dermatology life quality index) compared with placebo at week 16 (BE HEARD I and BE HEARD II, Q2W and Q4W).1
- Clinical responses (HiSCR50 and HiSCR75) were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75 at week 48 (observed case analysis; BE HEARD I and BE HEARD II, Q2W and Q4W).1
"Today, at the largest dermatology meeting of the year, we unveiled 48-week data from our Phase 3 bimekizumab program in hidradenitis suppurativa. Results from the Phase 3 program highlight the meaningful clinical outcomes achieved by targeting IL-17F in addition to IL-17A," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "We are now focused on the next steps with global regulatory filings for bimekizumab in hidradenitis suppurativa planned for later this year."
The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed.1 The most common (frequency of >5 percent) treatment emergent adverse events on bimekizumab over 16 weeks were hidradenitis (7.2 percent in BE HEARD I and 8.8 percent in BE HEARD II), oral candidiasis (4.4 percent in BE HEARD I and 6.7 percent in BE HEARD II), headache (7.0 percent in BE
HEARD I and 5.8 in BE HEARD II), and diarrhea (7.0 percent in BE HEARD I and 5.3 percent in BE HEARD II).1
UCB expects to submit global regulatory applications for bimekizumab in moderate to severe HS starting in Q3 2023.
Notes to editors:± Observed case analysis.
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 (HS). BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe HS. 1
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 HS. BE HEARD II enrolled 509 participants with a diagnosis of moderate to severe HS.1
BE HEARD I and II comprised double-blind 16-week initial and 32-week maintenance treatment periods. Participants with moderate to severe HS were randomized 2:2:2:1 to (initial/maintenance) bimekizumab 320mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W, placebo/bimekizumab Q2W. Until week 16, bimekizumab Q2W/Q2W and bimekizumab Q2W/Q4W were combined to bimekizumab Q2W.1
The primary endpoint in both studies was HiSCR50 at week 16.1 A key secondary endpoint was HiSCR75 at week 16.1 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.2,3
For additional details on the studies, visit BE HEARD I and BE HEARD II on clinicaltrials.gov.2,3
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.4,5 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.4,5 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.4,5
HS develops in early adulthood and affects approximately one percent of the population in most studied countries.4,5 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.6
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.7 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. 4,6
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.8 In August 2021, bimekizumab was first 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.9,10 The label information may differ in other countries where approved. Please check local prescribing information. In the U.S., the efficacy and safety of bimekizumab have not been established for any indication, and it is not approved by the U.S. Food and Drug Administration (FDA).
For further information, contact UCB:
Investor RelationsAntje WitteT +32.2.559.94.14Email [email protected]
U.S. Communications, ImmunologyNicole HergaT +1.773.960.5349Email [email protected]
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 €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward- looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems.
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UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
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- 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. Late- Breaking Platform Presentation at the 2023 American Academy of Dermatology Annual Meeting.
- ClinicalTrials.gov. A Study to Evaluate 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/NCT042424461. Last accessed: March 2023
- ClinicalTrials.gov. A Study to Evaluate 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: March 2023
- 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;6:18.
- Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421–430.
- Koumaki D, Ourania E, 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, December 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last Accessed: March 2023.
- BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last accessed: March 2023.
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