New Two-Year Data Showed Bimekizumab Maintained High Levels of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis – PRNewswire

BRUSSELS, Belgium and ATLANTA, Aug. 7, 2021 /PRNewswire/ --UCB, a global biopharmaceutical company, announced today new interim data from BE BRIGHT, an open-label extension (OLE) trial to assess the long-term safety, tolerability and efficacy of bimekizumab, an investigational IL-17A and IL-17F inhibitor, in adults with moderate to severe plaque psoriasis.1,2These results were presented today during a platform presentation at the 2021 American Academy of Dermatology (AAD) Summer Meeting, Tampa, Florida, U.S.

Data presented showed that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks (Q4W) or every eight weeks (Q8W).1The efficacy and safety of bimekizumab have not been established and it is not approved by any regulatory authority worldwide.

"These interim results from the BE BRIGHT study highlight the potential of bimekizumab to provide lasting skin clearance to adults living with moderate to severe plaque psoriasis," said Mark Lebwohl, MD, Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman emeritus, Kimberly and Eric J. Waldman Department of Dermatologyand Presenting Author of the data at the AAD Summer Meeting. "These data are meaningful for the dermatology community and further add to the clinical evidence we have from the bimekizumab Phase 3 clinical program."

"Given the chronic nature of psoriasis, physicians and patients value treatment options that can offer long-term disease control," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "We are pleased to share the first presentation of bimekizumab data from the BE BRIGHT study highlighting the potential of bimekizumab to provide complete skin clearance that can last through to two years in adult patients with moderate to severe plaque psoriasis."

Results shared today report on the maintenance of the Investigator's Global Assessment (IGA) of Clear or Almost Clear skin (IGA 0/1), Body Surface Area (BSA) 1%, and Psoriasis Area and Severity Index (PASI) 100 through to two years of bimekizumab treatment.1Analyses included patients randomized to bimekizumab 320 mg Q4W who exhibited a response at week 16 in one of the pivotal Phase 3 studies (BE READY, BE VIVID, BE SURE), received bimekizumab 320 mg Q4W or Q8W maintenance dosing from week 16, and continued with the same maintenance dosing in the open-label BE BRIGHT study, i.e., Q4W/Q4W/Q4W or Q4W/Q8W/Q8W.1

Initially, 989 patients were randomized to bimekizumab Q4W. At week 16, 87.5 percent achieved IGA 0/1, 74.9 percent achieved BSA 1% and 62.7 percent achieved PASI 100. Among week 16 IGA 0/1 responders, over nine out of 10 patients maintained IGA 0/1 to week 48 in the OLE trial (94.4 and 96.2 percent with continuous Q4W and Q8W maintenance dosing, respectively).1Similarly, among week 16 BSA 1% responders, over nine out of 10 patients maintained BSA 1% to week 48 in the OLE trial (90.7 and 92.5 percent with continuous Q4W and Q8W maintenance dosing, respectively). Over eight out of 10 patients who achieved complete skin clearance (PASI 100) at week 16 maintained response to week 48 in the OLE trial (80.7 and 86.1 percent with continuous Q4W and Q8W maintenance dosing, respectively).1

In BE READY, BE VIVID and BE SURE, the most frequently reported treatment-emergent adverse events in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection.3,4,5,6

Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults. On June 25th, 2021, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending granting a marketing authorization for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The final decision of the European Commission on marketing authorization is expected within approximately two months of the CHMP opinion.

About BE BRIGHT2BE BRIGHT (NCT03598790) is an ongoing, multicentre, open-label extension study assessing the long-term safety, tolerability and efficacy of bimekizumab in adult patients with moderate to severe plaque psoriasis. 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. More details can be found at ClinicalTrials.gov.

About bimekizumab Bimekizumab is an investigational humanized IgG1 monoclonal antibody that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes.4,5,6 Selective inhibition of IL-17F in addition to IL-17A has been shown to suppress inflammation to a greater extent than IL-17A inhibition alone.4,5,6

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

AboutPsoriasisPsoriasis is a common, chronic inflammatory disease with primary involvement of the skin.7This skin condition affects men and women of all ages and ethnicities.7Psoriasis 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.8Psoriasis also has a considerable psychological and quality-of-life impact, potentially affecting work, recreation, relationships, sexual functioning, family and social life.9

Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately one in three 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.10

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.

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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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For further information, contact UCB:

Corporate Communications

Laurent Schots,

Media Relations, UCB

T +32.2.559.92.64

[emailprotected]

Investor Relations

Antje Witte,

Investor Relations, UCB

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[emailprotected]

Brand Communications

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Brand Communications, UCB

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Allyson FunkU.S. Communications, UCBT +1 770 970 8338[emailprotected]

References

1

Strober B, Asahina A, Mrowietz U, et al. Bimekizumab response maintenance through two years of treatment in patients with moderate to severe plaque psoriasis who responded after 16 weeks: Interim results from the BE BRIGHT open-label extension trial. Abstract presented at AAD Summer 2021

2

ClinicalTrials.gov. Available at https://clinicaltrials.gov/ct2/show/NCT03598790Last accessed: August 2021.

3

UCB Data on File, July 2021.

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: August2021.

8

International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/our-cause.Last accessed: August2021.

9

Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermatol Ther (Heidelb). 2013;3(2):117-130.

10

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.

SOURCE UCB

http://www.ucb.com

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New Two-Year Data Showed Bimekizumab Maintained High Levels of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis - PRNewswire