UCB to Present 12 Abstracts on Bimekizumab at AAD VMX 2021

Brussels, Belgium – April 23, 2021, 16:15 CEST – UCB, a global biopharmaceutical company, today announced that 12 abstracts on bimekizumab, an investigational IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis, will be presented at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), April 23 - 25, 2021. This will include 11 e-posters and an oral presentation of late-breaking data from the Phase 3b BE RADIANT study evaluating the efficacy and safety of bimekizumab compared to secukinumab in the treatment of moderate to severe plaque psoriasis. The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.

“We are proud to join the dermatology community at AAD VMX 2021 to share the latest data from the clinical development program of bimekizumab in psoriasis. The breadth of bimekizumab data being shared across 12 abstracts reinforces our commitment to advancing research and science in psoriasis. It is a privilege to share these findings and we look forward to engaging with the dermatology community in our efforts to address the unmet needs of people with psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. 

Data being shared at AAD VMX include the presentation of pooled results from three Phase 3 trials (BE VIVID, BE READY and BE SURE), that compared the efficacy and safety of bimekizumab to ustekinumab, placebo and adalimumab, respectively, in adult patients with moderate to severe plaque psoriasis. 

Additional data from BE SURE to be presented include an assessment of bimekizumab efficacy in patients receiving continuous bimekizumab treatment or switching from adalimumab and the relationship between treatment efficacy and quality of life in patients receiving bimekizumab or adalimumab. 

Two other bimekizumab abstracts will include the first disclosure of data from the novel, validated Psoriasis Symptoms and Impacts Measure (P-SIM) from the BE VIVID and BE SURE studies.

UCB data presentations at AAD VMX 2021:

Bimekizumab Late-Breaking Oral Presentation:

• Bimekizumab efficacy and safety versus secukinumab in patients with moderate to severe plaque psoriasis: Results from a multicenter, randomized, double-blinded, active comparator-controlled phase 3b trial (BE RADIANT), K. Reich, R. Warren, M. Lebwohl, M. Gooderham, B. Strober, R. Langley, C. Paul, L. Peterson, V. Vanvoorden, C. Madden, A. Blauvelt (abstract #29010)

Bimekizumab e-Posters:

• Bimekizumab response maintenance up to 1 year in patients with moderate to severe plaque psoriasis: Pooled results from three phase 3 trials, A. Blauvelt, Y. Tada, L. Iversen, U. Mrowietz, M. Lebwohl, M. Wang, V. Vanvoorden, E. Cullen, F. Staelens, K. Papp (abstract #27383)

• Bimekizumab efficacy for moderate to severe plaque psoriasis across patient subgroups: Pooled results from three multicenter, randomized, double-blinded phase 3 trials, B. Strober, R. Warren, P. Foley, M. Gooderham, D. Thaçi, E. Cullen, C. Cioffi, L. Peterson, C. Madden, A. Armstrong (abstract #25934)

• Speed of clinical response and improvement in psoriasis with bimekizumab: Pooled results from the multicenter, randomized, double-blinded phase 3 BE VIVID, BE READY and BE SURE trials, M. Lebwohl, P. Hampton, A. Morita, K. Reich, J. Lambert, E. Cullen, C. Cioffi, M. Wang, C. Madden, R. Langley (abstract #27376)

• Bimekizumab efficacy in patients with moderate to severe plaque psoriasis receiving continuous bimekizumab or switching from adalimumab: Results from the phase 3 BE SURE trial, B. Strober, A. Pinter, R. Warren, A. Blauvelt, M. Sebastian, D. Cuyper, V. Vanvoorden, M. Wang, C. Madden, M. Gooderham (abstract #27374)

• Bimekizumab for the treatment of moderate to severe psoriasis of the scalp: Post-hoc analysis from the BE SURE phase 3 trial, K. Reich, J. Merola, B. Elewski, K. Papp, L. Puig, P. Rich, C. Cioffi, E. Cullen, L. Peterson, A. Gottlieb (abstract #25800)

• Bimekizumab versus adalimumab in plaque psoriasis: Higher efficacy translates into improvements in quality of life in the BE SURE multicenter, randomized, double-blinded phase 3 trial, A. Blauvelt, D. Thaci, K. Papp, J. Merola, E. Cullen, V. Vanvoorden, V. Ciaravino, L. Peterson, K. Gordon (abstract #27464)

• Psoriasis Symptoms and Impacts Measure (P-SIM) responses from the BE SURE bimekizumab in moderate to severe plaque psoriasis phase 3 trial, R. Warren, M. Augustin, A. Gottlieb, K. Duffin, V. Ciaravino, C. Cioffi, L. Peterson, A. Blauvelt (abstract #27373)

• Psoriasis Symptoms and Impacts Measure (P-SIM) responses from the BE VIVID bimekizumab in moderate to severe plaque psoriasis phase 3 trial, R. Warren, R. Langley, A. Asahina, M. Augustin, J. Merola, A. Gottlieb, V. Ciaravino, C. Cioffi, L. Peterson, M. Lebwohl (abstract #27368)

• Bimekizumab efficacy in patients with moderate to severe plaque psoriasis during the randomized withdrawal and retreatment phase of BE READY, a phase 3 trial, A. Blauvelt, J. Wu, K. Reich, M. Gooderham, M. Lebwohl, K. White, N. Cross, C. Cioffi, K. Papp (abstract #27380)

• Bimekizumab short-term and longer-term anxiety, depression, and suicidal ideation/behavior in patients with moderate to severe plaque psoriasis: Analysis of pooled data from eight phase 2/3 clinical trials, B. Strober, K. Papp, A. Blauvelt, M. Lebwohl, J. Wu, D. Deherder, C. Madden, K. Wixted, M. Wang, M. Augustin (abstract #27505)

• Bimekizumab short-term and longer-term infection rates in patients with moderate to severe plaque psoriasis: Analysis of pooled data from eight phase 2/3 clinical trials, K. Reich, Y. Okubo, K. Gordon, A. Blauvelt, A. Armstrong, D. Cuyper, C. Cioffi, L. Peterson, M. Lebwohl (abstract #27468)

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.¹ IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.^2,3,4,5,6  Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.^5,6 The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program. 

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvement of the skin. This skin condition affects men and women of all ages and ethnicities.⁷ Psoriasis signs and symptoms can vary but may include red patches of skin covered with silvery scales; dry, cracked skin that may bleed; and thickened, pitted or ridged nails.⁸

Approximately 125 million people worldwide are living with psoriasis, nearly three percent of the world’s population.^9,10 Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately 30 percent of psoriasis patients reported that their primary goals of therapy, including keeping symptoms under control, reducing itching and decreasing flaking, were not met with their current treatment.¹¹  Psoriasis has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.¹²

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 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

Forward looking statements UCB
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’ 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. 

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

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. 

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. 

For further information, UCB:

Corporate Communications
Laurent Schots 
Media Relations, UCB  
T+32.2.559.92.64  Laurent.schots@ucb.com 

Investor Relations
Antje Witte          
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com 

Brand Communications
Eimear O’Brien,
Brand Communications, UCB
T + 32.2.559.92.71
eimear.obrien@ucb.com 

References:

1. 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.
2. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.
3. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fold: structure and activity of a novel cytokine, IL-17F, and implications for receptor binding. EMBO J. 2001;20(19):5332–5341.
4. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. 2014;16(4):426.
5. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
6. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomised placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
7. National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: March 2021.
8. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause/. Last accessed: March 2021.
9. Griffiths C, van der Walt J, et al. The global state of psoriasis disease epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4 e7.
10. World Health Organization. Global report on psoriasis, 2016. Available at: http://apps.who.int/iris/handle/10665/204417. Last accessed: March 2021.
11. Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Management of Psoriasis and Psoriatic Arthritis: Patient and Physician Results from the Population-Based Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) Survey. Am J Clin   Dermatol. 2016;17(1):87-97.
12. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.