• Three-year data from the BE BRIGHT open-label extension study are being presented at the 31st EADV Congress
• Over eight out of 10 patients who achieved complete skin clearance (PASI 100) at week 16 maintained PASI 100 responses and health-related quality of life outcomes through to three years 
• Analysis of pooled safety data from up to three years of treatment in Phase 2 and 3 clinical trials showed bimekizumab was generally well tolerated with no new safety signals identified over three years

Brussels and Atlanta, September 7, 2022 – 07:00 ET – UCB, a global biopharmaceutical company, today announced new three-year results from the BE BRIGHT open-label extension (OLE) study evaluating the long-term safety, tolerability and efficacy of bimekizumab in adults with moderate to severe plaque psoriasis who completed one of three pivotal Phase 3 studies.¹ These data, together with a three-year safety analysis of pooled data from Phase 2 and Phase 3 studies,² are being presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress in Milan, Italy, September 7-10. A total of 11 abstracts highlighting data related to bimekizumab in psoriasis are being presented at the congress. 

Data presented from the BE BRIGHT OLE study showed that over eight out of 10 patients who achieved complete skin clearance (PASI 100) following 16 weeks of bimekizumab treatment maintained PASI 100 response and health-related quality of life outcomes through to three years with continuous maintenance dosing. In addition, approximately nine out of 10 patients who achieved absolute PASI (PASI ≤2) at week 16 maintained this response through to three years.¹ Pooled data from up to three years of treatment in Phase 2 and 3 clinical trials showed that bimekizumab was generally well-tolerated over this period with no safety signals identified.²  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).

“These positive results highlight the deep and long-lasting skin clearance achieved with bimekizumab, along with a consistent safety and tolerability profile, and reinforce the positive relationship clearing skin has on patients’ quality of life. These new data add to the growing body of evidence supporting longer-term use of bimekizumab in moderate to severe plaque psoriasis,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. 

“The findings presented today show that bimekizumab provided maintenance of completely clear skin and health-related quality of life outcomes in the majority of patients with moderate to severe plaque psoriasis over a three year period,” said Dr. Bruce Strober, Clinical Professor of Dermatology at Yale University, New Haven, Conn. “The goal of psoriasis treatment often is complete clearance of skin symptoms, and the availability of long-term data across treatment options is important since it supports healthcare providers and patients to be more informed when making treatment decisions.”

Three-year data from the BE BRIGHT OLE study
All patients who had completed one of the pivotal Phase 3 studies (BE SURE, BE VIVID and BE READY) were eligible to enter the BE BRIGHT OLE study.¹ On OLE entry, patients were assigned to bimekizumab 320 mg every four weeks (Q4W) or every eight weeks (Q8W) based on PASI 90 response at the end of the respective Phase 3 study. 

 In all bimekizumab-randomized patients:^1¥

• Among week 16 PASI 100 responders (N=503), 89.3 percent achieved PASI 100 at year one (week 52) and 82.0 percent at year three (OLE week 96)
• Among week 16 PASI ≤2 responders (N=694), 96.5 percent achieved PASI ≤2 at year one (week 52) and 94.2 percent at year three (OLE week 96)
• Among week 16 PASI 100 responders in BE SURE and BE READY only (N=330), 92.0 percent achieved the Dermatology Life Quality Index (DLQI) 0/1 at year one (week 56), and 88.0 percent at year three (OLE week 96)

In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] through three years, BE SURE and BE READY only):^1¥

• Among week 16 PASI 100 responders (N=147), 93.6 percent achieved PASI 100 at year one (week 52) and 84.4 percent at year three (OLE week 96)
• Among week 16 PASI ≤2 responders (N=189), 98.9 percent achieved PASI ≤2 at year one (week 52) and 96.8 percent at year three (OLE week 96)
• Among week 16 PASI 100 responders (N=147), 95.8 percent achieved DLQI 0/1 at year one (week 56) and 92.5 percent at year three (OLE week 96)

Pooled safety data from up to three years of treatment in Phase 2 and 3 clinical trials
Total bimekizumab exposure was 4245.3 patient-years (PY; N=1789) across the Phase 2 and 3 trials, and 3876.4 PY (N=1495; Q4W: 1965.6 PY; Q8W: 1914.5 PY) in the Phase 3 trials.² Treatment emergent adverse events (TEAEs) occurred at an exposure-adjusted incidence rate (EAIR) of 186.1 per 100 PY: serious TEAEs were seen at an EAIR of 5.6 new cases per 100 PY and TEAEs leading to discontinuation at 3.5 new cases per 100 PY.² 

The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nasopharyngitis, oral candidiasis and upper respiratory tract infection at EAIRs of 15.3, 10.2 and 7.1 new cases per 100 PY, respectively.² The EAIR for oral candidiasis showed a decrease compared with two years of bimekizumab treatment (10.2 versus 12.6 new cases per 100 PY) and was lower with bimekizumab dosed Q8W compared with Q4W (7.1 and 15.9 per 100 PY, respectively).² The vast majority of oral candidiasis events were mild to moderate (99.4 percent), and none were serious.² Serious infections occurred at a rate of 1.2/100 PY. The most frequently reported were serious coronavirus infections (0.2 per 100 PY).² 

^¥ Modified non-responder imputation analyses

Notes to editors :

About BE BRIGHT
BE BRIGHT (NCT03598790) is an ongoing, multicenter, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe chronic plaque psoriasis.³ Patients who completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and BE SURE, were eligible to enroll in the BE BRIGHT study.⁴ More details on BE BRIGHT can be found at ClinicalTrials.gov.³

BE VIVID, BE READY and BE SURE evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe plaque psoriasis versus placebo and ustekinumab, versus placebo, and versus adalimumab, respectively.^4,5,6

About psoriasis
Psoriasis is a chronic inflammatory disease with primary involvement of the skin.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 Psoriasis also has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.⁹ This skin condition affects men and women of all ages and ethnicities.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.^10,11

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.^10,12 In January 2022, bimekizumab received marketing authorization in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and psoriatic erythroderma in patients who are not sufficiently responding to existing treatments.13 In February and March 2022, bimekizumab was approved in Canada and Australia, respectively, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.^14,15

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).

For further information, contact UCB: 

Investor Relations
Antje Witte
T: +32.2.559.94.14 
email: antje.witte@ucb.com 

U.S. Immunology Communications
Nicole Herga
T: +1.404.226.7591
email: nicole.herga@ucb.com 

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: @UCB_news.

Forward looking statements 
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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. 

References

1. Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. Abstract presented at the 31st EADV Congress.
2. Gordon KB, Langley RG, Warren RB et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to three years of treatment in phase 2 and 3 clinical trials. Abstract presented at the 31st EADV Congress.
3. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790 Last accessed August 2022.
4. 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. 2021;397(10273):487-498.
5. 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. 2021;397(10273):475-486. 
6. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
7. National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/. Last accessed: August 2022
8.  NHS. Psoriasis Symptoms. Available at: https://www.nhs.uk/conditions/psoriasis/symptoms/. Last accessed: August 2022. 
9. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.
10. BIMZELX (bimekizumab) EU Summary of Product Characteristics, March 2022. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf Last accessed August 2022.
11. 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.
12. BIMZELX® (bimekizumab) GB Summary of Product Characteristics. https://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/emc/product/12833 Last accessed: August 2022.
13. Pharmaceuticals and Medical Devices Agency. Available at: https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html Last accessed: August 2022.
14. BIMZELX (bimekizumab) Canada Product Monograph. Available at: https://pdf.hres.ca/dpd_pm/00064702.PDF Last accessed: August 2022.
15. BIMZELX (bimekizumab) Australia. Available at: https://www.tga.gov.au/apm-summary/bimzelx.Last accessed August 2022.
     

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