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UCB Media Room: UCB to Present 12 Abstracts on Bimekizumab at AAD VMX 2021


[23/04/2021 | 16:26]

** UCB to Present 12 Abstracts on Bimekizumab at AAD VMX 2021

Brussels, Belgium =E2=80=93 April 23, 2021, 16:15 CEST =E2=80=93 UCB, a glo=
bal biopharmaceutical company, today announced that 12 abstracts on bimekiz=
umab, an investigational IL-17A and IL-17F inhibitor, in the treatment of a=
dults with moderate to severe plaque psoriasis, will be presented at the Am=
erican Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), Ap=
ril 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 eff=
icacy and safety of bimekizumab compared to secukinumab in the treatment of=
moderate to severe plaque psoriasis. The safety and efficacy of bimekizuma=
b have not been established and it is not approved by any regulatory author=
ity worldwide.

=E2=80=9CWe 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 abstra=
cts reinforces our commitment to advancing research and science in psoriasi=
s. It is a privilege to share these findings and we look forward to engagin=
g with the dermatology community in our efforts to address the unmet needs =
of people with psoriasis,=E2=80=9D said Emmanuel Caeymaex, Executive Vice P=
resident, Immunology Solutions and Head of U.S., UCB.=C2=A0

Data being shared at AAD VMX include the presentation of pooled results fro=
m 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 bimek=
izumab efficacy in patients receiving continuous bimekizumab treatment or s=
witching from adalimumab and the relationship between treatment efficacy an=
d quality of life in patients receiving bimekizumab or adalimumab.=C2=A0

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

UCB data presentations at AAD VMX 2021:

Bimekizumab Late-Breaking Oral Presentation:

=C2=B7 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:

=C2=B7 Bimekizumab response maintenance up to 1 year in patients with moder=
ate to severe plaque psoriasis: Pooled results from three phase 3 trials, A=
. Blauvelt, Y. Tada, L. Iversen, U. Mrowietz, M. Lebwohl, M. Wang, V. Vanvo=
orden, E. Cullen, F. Staelens, K. Papp (abstract #27383)

=C2=B7 Bimekizumab efficacy for moderate to severe plaque psoriasis across =
patient subgroups: Pooled results from three multicenter, randomized, doubl=
e-blinded phase 3 trials, B. Strober, R. Warren, P. Foley, M. Gooderham, D.=
Tha=C3=A7i, E. Cullen, C. Cioffi, L. Peterson, C. Madden, A. Armstrong (ab=
stract #25934)

=C2=B7 Speed of clinical response and improvement in psoriasis with bimekiz=
umab: 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. Langle=
y (abstract #27376)

=C2=B7 Bimekizumab efficacy in patients with moderate to severe plaque psor=
iasis receiving continuous bimekizumab or switching from adalimumab: Result=
s from the phase 3 BE SURE trial, B. Strober, A. Pinter, R. Warren, A. Blau=
velt, M. Sebastian, D. Cuyper, V. Vanvoorden, M. Wang, C. Madden, M. Gooder=
ham (abstract #27374)

=C2=B7 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. Mero=
la, B. Elewski, K. Papp, L. Puig, P. Rich, C. Cioffi, E. Cullen, L. Peterso=
n, A. Gottlieb (abstract #25800)

=C2=B7 Bimekizumab versus adalimumab in plaque psoriasis: Higher efficacy t=
ranslates 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 (a=
bstract #27464)

=C2=B7 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. Pe=
terson, A. Blauvelt (abstract #27373)

=C2=B7 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. Ci=
aravino, C. Cioffi, L. Peterson, M. Lebwohl (abstract #27368)

=C2=B7 Bimekizumab efficacy in patients with moderate to severe plaque psor=
iasis 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)

=C2=B7 Bimekizumab short-term and longer-term anxiety, depression, and suic=
idal 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)

=C2=B7 Bimekizumab short-term and longer-term infection rates in patients w=
ith 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 s=
electively and directly inhibits both IL-17A and IL-17F, two key cytokines =
driving inflammatory processes.^1=C2=A0IL-17F has overlapping biology with =
IL-17A and drives inflammation independently of IL-17A.^2,3,4,5,6=C2=A0 Sel=
ective inhibition of IL-17F in addition to IL-17A suppresses inflammation t=
o a greater extent than IL-17A inhibition alone.^5,6 The safety and efficac=
y of bimekizumab are being evaluated across multiple disease states as part=
of a robust clinical program.=C2=A0

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin. This skin condition affects men and women of all ages and et=
hnicities.^7=C2=A0Psoriasis signs and symptoms can vary but may include red=
patches of skin covered with silvery scales; dry, cracked skin that may bl=
eed; and thickened, pitted or ridged nails.^8

Approximately 125 million people worldwide are living with psoriasis, nearl=
y three percent of the world=E2=80=99s population.^9,10=C2=A0Unmet needs re=
main in the treatment of psoriasis. A population-based survey identified th=
at approximately 30 percent of psoriasis patients reported that their prima=
ry goals of therapy, including keeping symptoms under control, reducing itc=
hing and decreasing flaking, were not met with their current treatment.^11=
=C2=A0 Psoriasis has a considerable psychological and quality-of-life impac=
t, potentially affecting work, recreation, relationships, sexual functionin=
g, family and social life.^12

About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,400 peopl=
e in nearly 40 countries, the company generated revenue of =E2=82=AC5.3 bil=
lion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us o=
n Twitter: @UCB_news.

Forward looking statements UCB
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
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es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e 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 relea=
se. Important factors that could result in such differences include: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
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es 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 b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products which are the subject of partnersh=
ips, joint ventures or licensing collaborations may be subject to differenc=
es 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 pa=
rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
to integrate the operations of such acquired companies may not be as succes=
sful as UCB may have believed at the moment of acquisition. Also, UCB or ot=
hers could discover safety, side effects or manufacturing problems with its=
products and/or devices after they are marketed. The discovery of signific=
ant problems with a product similar to one of UCB=E2=80=99s products that i=
mplicate an entire class of products may have a material adverse effect on =
sales of the entire class of affected products. Moreover, sales may be impa=
cted by international and domestic trends toward managed care and health ca=
re cost containment, including pricing pressure, political and public scrut=
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olicies imposed by third-party payers as well as legislation affecting biop=
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breakdown, cyberattack or information security breach could compromise the=
confidentiality, integrity and availability of UCB=E2=80=99s data and syst=

Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =

UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0

Additionally, information contained in this document shall not constitute a=
n 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 jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=

For further information, UCB:

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
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=C2=A0

Brand Communications
Eimear O=E2=80=99Brien,
Brand Communications, UCB
T + 32.2.559.92.71


1. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual=C2=A0inhibito=
r of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):=
2. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses b=
y IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
3. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fo=
ld: structure and activity of a novel cytokine, IL-17F, and=C2=A0implicatio=
ns for receptor binding. EMBO J. 2001;20(19):5332=E2=80=935341.
4. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous express=
ion pattern of interleukin 17A (IL-17A), IL-17F and their=C2=A0receptors in=
synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: =
possible explanation for nonresponse to anti-IL-17=C2=A0therapy? Arthritis =
Res Ther. 2014;16(4):426.
5. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-1=
7A and IL-17F provides evidence of IL-17F contribution to=C2=A0chronic infl=
ammation 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=C2=A0expe=
riments and a randomised placebo-controlled clinical trial that IL-17F cont=
ributes to human chronic tissue inflammation. Ann Rheum=C2=A0Dis. 2018;77(4=
7. National Psoriasis Foundation. About Psoriasis. Available at: https://ww=
w.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 diseas=
e epidemiology: a workshop report. Br J Dermatol. 2017;177(1):e4=C2=A0e7.
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 Man=
agement of Psoriasis and Psoriatic Arthritis: Patient and Physician Results=
from the Population-Based Multinational Assessment of Psoriasis and Psoria=
tic Arthritis (MAPP) Survey. Am J Clin =C2=A0 Dermatol. 2016;17(1):87-97.
12. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat=
ol Ther (Heidelb). 2013;3(2):117-130.

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