The Lancet Publishes Two Phase 3 Studies Detailing Bimekizumab Data in Moderate to Severe Plaque Psoriasis

Brussels, Belgium – EMBARGOED FOR RELEASE: February 4, 2021, 23:30 PM GMT – UCB, a global biopharmaceutical company, today announced that The Lancet has published results from BE VIVID and BE READY, two Phase 3 studies evaluating the efficacy and safety profile of bimekizumab, its investigational IL-17A and IL-17F inhibitor, in the treatment of adults with moderate to severe plaque psoriasis.^1,2  The manuscripts of these two studies, published back to back, are the first publications from the Phase 3 clinical development program of bimekizumab in psoriasis. A comment piece accompanying these manuscripts is also published today. 

“The simultaneous publication of data from two bimekizumab Phase 3 studies in one of medicine’s most authoritative titles, The Lancet, speaks to the significance of these psoriasis studies. We’re grateful to the patients and investigators who participated in the studies, and we’re committed to working with the regulatory agencies to bring bimekizumab to patients,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of US, UCB.

Data from BE VIVID and BE READY showed that both studies met their co-primary endpoints, demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance, at week 16, compared to those who received placebo or ustekinumab, as measured by at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.0001 for both comparisons.^1,2 These results were further supported by both studies meeting all ranked secondary endpoints including PASI 100 at week 16, PASI 75 at week 4, PASI 90 at week 52 (BE VIVID) and PASI 90 at week 56 in patients who achieved PASI 90 at week 16 (BE READY).^1,2 The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified.^1,2,3,4  

Data from the BE VIVID and BE READY studies were included in the marketing application submissions to the FDA and EMA. In September 2020, UCB announced that the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA) for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults had been accepted by the FDA and EMA, respectively. 

The safety and efficacy of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.  

About the BE VIVID study¹
BE VIVID was a Phase 3 multicentre, randomized, double-blinded, placebo- and active comparator-controlled trial comparing the efficacy and safety of bimekizumab with placebo and ustekinumab in adult patients with moderate to severe plaque psoriasis over 52 weeks. Patients (n=567) were randomized 4:2:1 to bimekizumab 320 mg every four weeks (Q4W), ustekinumab 45/90 mg (baseline weight‑dependent dosing) at weeks 0/4, then every 12 weeks (Q12W), or placebo Q4W. At week 16, patients receiving placebo switched to bimekizumab 320 mg Q4W. The co-primary endpoints were proportions of patients achieving 90 percent improvement in the PASI 90 and ‘clear’ or ‘almost clear’ skin in the IGA (0/1) at week 16. 

About the BE READY study²

BE READY was a Phase 3, multicentre, randomized, double-blinded, placebo-controlled trial. This study investigated the efficacy and safety of bimekizumab in adult patients with moderate to severe plaque psoriasis, the effects of treatment withdrawal, and two maintenance dosing schedules over 56 weeks. Patients (n=435) were randomized 4:1 to bimekizumab (320 mg every four weeks; Q4W) or placebo Q4W.  Bimekizumab-treated patients achieving PASI 90 at week 16 were re-randomized 1:1:1 to bimekizumab 320 mg Q4W, Q8W, or placebo for weeks 16–56. The co-primary endpoints were proportions of patients achieving 90 percent improvement in the PASI 90 and ‘clear’ or ‘almost clear’ skin in the IGA (0/1) at week 16. 

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.⁵ IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.^6,7,8,9,10  Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone.^9,10 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.¹¹ 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.¹²

Psoriasis affects nearly three percent of the population, and approximately 125 million people worldwide have psoriasis.^13,14 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.¹⁵ Psoriasis has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.¹⁶ 

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

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eimear.obrien@ucb.com

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Investor Relations, UCB
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 Investor Relations, UCB
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References: 

1. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00125-2/fulltext
2. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00126-4/fulltext
3. Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10.
4. Blauvelt A, Merola JF, Papp KA, et al. Durability of responses with bimekizumab, a selective dual inhibitor of interleukin (IL)-17A and -17F, in moderate-to-severe chronic plaque psoriasis in a 60-week randomized, double-blinded, Phase 2b study (BE ABLE 2). J Am Acad Dermatol. 2020;83(5):1367-1374.
5. 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.
6. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5):1063–1075.
7. 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.
8. 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.
9. 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.
10. 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.
11. National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: January 2021.
12. International Federation of Psoriasis Associations. Available at: www.ifpa-pso.com/our-cause//. Last accessed: January 2021.
13. National Psoriasis Foundation. Statistics. Available at: www.psoriasis.org/content/statistics. Last accessed: January 2021.
14. World Health Organization. Global report on psoriasis, 2016. Available at: http://apps.who.int/iris/handle/10665/204417. Last accessed: January 2021.
15. 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.
16. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.