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Bimekizumab Phase 3 Data Shows Superior Skin Clearance Over Humira[®] in Moderate-to-Severe Psoriasis Patients

· Data from the Phase 3 BE SURE study demonstrated that patients treated with investigational IL-17A and IL-17F inhibitor bimekizumab achieved significantly higher PASI 90 and PASI 100 skin clearance rates, compared to Humira[®] (adalimumab), at week 16, which were maintained up to one year with both four and eight week dosing · Skin clearance rates rapidly increased in patients who switched from adalimumab to bimekizumab at week 24, with response rates at week 56 comparable to patients treated with bimekizumab throughout the study

Brussels, Belgium – October 31, 2020 – UCB, a global biopharmaceutical company, today announced the detailed results of the head-to-head Phase 3 BE SURE study, which demonstrated that patients treated with investigational IL-17A and IL-17F inhibitor bimekizumab achieved superior skin clearance, as compared to adalimumab, in adults with moderate-to-severe plaque psoriasis.1 These findings were presented for the first time as an oral presentation at the European Academy of Dermatology and Venereology Congress, taking place virtually between October 29-31, 2020.

BE SURE met all primary and secondary ranked endpoints.1 The co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator Global Assessment (IGA) of clear or almost clear (IGA 0/1) versus adalimumab at week 16. Secondary endpoints included PASI 90 and IGA 0/1 at weeks 24 and 56, and PASI 100 at weeks 16 and 24. 

In BE SURE, patients treated with bimekizumab achieved significantly higher PASI 90, IGA 0/1 and PASI 100 skin clearance rates compared to patients treated with adalimumab at week 16.1 In patients that started bimekizumab at baseline, response rates were maintained up to a year. Rapid increases in skin clearance rates were seen in patients who switched from adalimumab to bimekizumab at week 24.1 The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.

“In BE SURE, we saw significantly higher skin clearance rates with bimekizumab compared with one of the most commonly used biologic treatments in psoriasis. The study results also demonstrated the potential benefits of switching patients who are being treated with adalimumab to bimekizumab,” said study investigator, Professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, United Kingdom.

“These findings from BE SURE, the third positive study in the psoriasis clinical development program, are further evidence of bimekizumab’s superior depth of response. The results also add to the mounting evidence supporting the potential value of selective inhibition of IL-17F, in addition to IL-17A, for rapid, complete and durable skin clearance, if approved by health authorities. UCB is proud to be developing innovative solutions for psoriasis patients,” said Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Head of US, UCB.

In BE SURE, 86.2 percent of patients treated with bimekizumab achieved almost clear skin (PASI 90), compared with 47.2 percent of patients treated with adalimumab at week 16 (p<0.001).1 Additionally, 85.3 percent of patients treated with bimekizumab achieved IGA 0/1, versus 57.2 percent of patients treated with adalimumab at week 16 (p<0.001).1 Significantly more patients treated with bimekizumab achieved complete skin clearance (PASI 100) than those treated with adalimumab: 60.8 percent versus 23.9 percent at week 16, and 66.8 percent versus 29.6 percent at week 24 (p<0.001 for each comparison).1 

In the two bimekizumab study arms, PASI 90, PASI 100 and IGA 0/1 response rates were maintained through to week 56.1 These results were observed across both dosing regimens: bimekizumab every four weeks (Q4W dosing) until week 56, or Q4W dosing for 16 weeks, followed by bimekizumab every eight weeks (Q8W dosing) from week 16 to week 56.1 In patients treated with adalimumab, response rates for PASI 90, PASI 100 and IGA 0/1 rapidly increased after patients were switched to bimekizumab Q4W dosing at week 24, through to week 56.1 At week 56, response rates in switched patients were comparable to those who had been treated with bimekizumab throughout the study.1 

Through weeks 0–24, the active comparator period, treatment emergent adverse events (TEAEs) and serious TEAEs were comparable for patients receiving bimekizumab (71.5 percent and 1.6 percent, respectively) and adalimumab (69.8 percent and 3.1 percent).1 Through weeks 0–56, 81.4 percent and 5.1 percent of patients receiving bimekizumab (including those who switched from adalimumab) experienced TEAEs and serious TEAEs, respectively.1 The most common TEAEs that were observed for bimekizumab through weeks 0–56 were nasopharyngitis (20.9 percent), oral candidiasis (16.2 percent) and upper respiratory tract infection (9.0 percent).1 Through week 56, there were no suicidal ideation/behavior, inflammatory bowel disease, or major adverse cardiac events reported in patients treated with bimekizumab.1 

About BE SURE    
BE SURE is a Phase 3, randomized, double-blind study comparing the efficacy and safety of bimekizumab to adalimumab in adult patients with moderate-to-severe chronic plaque psoriasis. The active-controlled initial treatment period of 24 weeks is followed by a dose-blind maintenance treatment period until week 56. BE SURE enrolled 478 participants with chronic plaque psoriasis for at least six months prior to screening and with an affected body surface area of at least 10 percent, PASI of at least 12 and IGA score equal to or greater than three on a five-point scale.2  

The co-primary endpoints of the study were PASI 90 response (defined as a patient who achieves a 90 percent improvement in PASI) and IGA response (defined as clear or almost clear with at least a two-category improvement relative to baseline) at week 16. For additional details on the study, visit BE SURE on clinicaltrials.gov.2 UCB announced topline findings from BE SURE in December 2019. For additional details, visit: BE SURE on UCB.com

Humira® is a registered trademark of AbbVie, Inc.

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes.3 IL-17F has overlapping biology with IL-17A and drives inflammation independently to IL-17A.4,5,6,7,8 Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.7,8 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.9 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.10

Psoriasis affects nearly three percent of the population, or about 125 million people worldwide.6 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 more than 7,600 people in approximately 40 countries, the company generated revenue of € 4.9 billion in 2019. 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
Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.christopher@ucb.com 

  1. Warren R, Blauvelt A, Bagel J, et al. Bimekizumab efficacy and safety versus adalimumab in patients with moderate to severe plaque psoriasis: Results from a multicentre, randomised, double-blinded active comparator-controlled phase 3 trial (BE SURE). Abstract ID 1958. Presented at the virtual 29th European Academy of Dermatology and Venereology Congress, October 29-31, 2020.
  2. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE SURE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03412747. Last accessed: October 2020.
  3. 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.
  4. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: October 2020.
  10. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause//. Last accessed: October 2020.
  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;3:117-130.

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