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UCB Media Room: bimekizumab in the New England Journal of Medicine

INFORMATION REGLEMENTEE


[23/04/2021 | 16:23]
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** The New England Journal of Medicine Publishes Results from Two Bimekizum=
ab Phase 3 Studies in Moderate to Severe Plaque Psoriasis
------------------------------------------------------------

=C2=B7 Today, two manuscripts published back to back detail the full result=
s from the BE RADIANT and BE SURE studies, comparing the efficacy and safet=
y of bimekizumab to secukinumab and adalimumab, respectively
=C2=B7 Results from BE RADIANT were also shared today as a late-breaking or=
al presentation at AAD VMX 2021
=C2=B7 In BE RADIANT, bimekizumab was superior to secukinumab in achieving =
complete skin clearance (PASI 100) at week 16, the primary endpoint of the =
study, and at week 48, a ranked secondary endpoint =C2=A0
=C2=B7 Bimekizumab is currently under review by the U.S. Food and Drug Admi=
nistration (FDA) and the European Medicines Agency (EMA) for the treatment =
of moderate to severe plaque psoriasis in adults

Brussels, Belgium =E2=80=93 EMBARGOED UNTIL April 23, 2021: 16:15 CEST =E2=
=80=93 UCB, a global biopharmaceutical company, announced today that The Ne=
w England Journal of Medicine has published two manuscripts with results fr=
om BE RADIANT and BE SURE, two Phase 3 studies evaluating the efficacy and =
safety profile of bimekizumab, its investigational IL-17A and IL-17F inhibi=
tor, in the treatment of adults with moderate to severe plaque psoriasis.^1=
,2=C2=A0 Results from the Phase 3b BE RADIANT study were also shared today =
as a late-breaking oral presentation at the American Academy of Dermatology=
Virtual Meeting Experience 2021.^3=C2=A0BE RADIANT is the first Phase 3 st=
udy to compare the efficacy and safety of dual IL-17A and IL-17F inhibition=
versus IL-17A inhibition alone.^1=C2=A0

=E2=80=9CThe publication of data from BE RADIANT and BE SURE in The New Eng=
land Journal of Medicine underscores the significance of these studies to t=
he medical community, and closely follows the publication of the first two =
bimekizumab Phase 3 studies in The Lancet earlier this year=E2=80=9D, said =
Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head =
of U.S., UCB. =E2=80=9CResults published today reflect the high rates of co=
mplete skin clearance, PASI 100, at week 16, rapid response after one dose =
and durability of response up to one year seen with bimekizumab in previous=
studies.=E2=80=9D

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

BE RADIANT RESULTS

The Phase 3b BE RADIANT study compared the efficacy and safety of bimekizum=
ab to secukinumab in adults with moderate to severe plaque psoriasis.^1 The=
study met its primary endpoint, with significantly more patients treated w=
ith bimekizumab achieving complete skin clearance, as measured by a 100 per=
cent improvement from baseline in the Psoriasis Area and Severity Index (PA=
SI 100) at week 16, compared to those treated with secukinumab (61.7 percen=
t versus 48.9 percent, respectively; p<0.001).^1=C2=A0

The study also met all ranked secondary endpoints.^1 The superior levels of=
complete skin clearance observed at week 16 continued through to week 48, =
with 67.0 percent of patients treated with bimekizumab, achieving PASI 100,=
compared to 46.2 percent of patients treated with secukinumab (p<0.001).^1=
At week 48, both bimekizumab maintenance dosing groups (every four weeks [=
Q4W] and every eight weeks [Q8W]), showed higher rates of complete skin cle=
arance (PASI 100), compared with secukinumab (p<0.001).^1 In addition, at w=
eek 4, significantly more patients treated with bimekizumab achieved PASI 7=
5 compared to patients treated with secukinumab (71.0 percent versus 47.3 p=
ercent, respectively; p<0.001).^1

=E2=80=9CIn BE RADIANT, patients treated with bimekizumab achieved superior=
levels of complete skin clearance, PASI 100, compared with secukinumab-tre=
ated patients at week 16, the primary endpoint of the study, and up to 48 w=
eeks of therapy. At week 4, a faster onset of response was also observed wi=
th bimekizumab compared with secukinumab. =C2=A0Data from this study suppor=
t the value of inhibition of IL-17F in addition to IL-17A in the treatment =
of patients with moderate to severe plaque psoriasis.=E2=80=9D said Prof. K=
ristian Reich, M.D., Ph.D., Translational Research in Inflammatory Skin Dis=
eases, Institute for Health Services Research in Dermatology and Nursing, U=
niversity Medical Center Hamburg-Eppendorf, Germany.=C2=A0

Across the study duration, the most common treatment-emergent adverse event=
s (TEAEs) with bimekizumab were upper respiratory tract infections* (38.9 p=
ercent), oral candidiasis (19.3 percent) and urinary tract infection (6.7 p=
ercent).^1 Oral candidiasis cases were predominantly mild or moderate and n=
one led to discontinuation.^1 Over 48 weeks, the incidence of serious TEAEs=
was 5.9 percent with bimekizumab and 5.7 percent with secukinumab.^1=C2=A0

BE SURE RESULTS=C2=A0

The Phase 3 BE SURE study compared the efficacy and safety of bimekizumab t=
o adalimumab in adults with moderate to severe plaque psoriasis.^2 Results =
from the BE SURE study were previously reported at the European Academy of =
Dermatology and Venereology (EADV) Congress 2020.^4=C2=A0

BE SURE met its co-primary endpoints, demonstrating that bimekizumab-treate=
d patients achieved superior levels of skin clearance, at week 16, compared=
to those who received adalimumab, as measured by PASI 90 and Investigator=
=E2=80=99s Global Assessment (IGA) response of clear or almost clear skin (=
IGA 0/1); p<0.001 for both comparisons.^2 These results were further suppor=
ted by the study meeting all ranked secondary endpoints.^2 The safety profi=
le of bimekizumab was consistent with earlier clinical studies with no new =
safety signals identified.^5,6,7,8

In September 2020, UCB announced that the FDA and EMA had accepted the Comp=
any=E2=80=99s Biologics License Application (BLA) and Marketing Authorizati=
on Application (MAA), respectively, for bimekizumab for the treatment of mo=
derate to severe plaque psoriasis in adults. UCB is committed to bringing b=
imekizumab to patients worldwide and additional regulatory filings are unde=
rway.

*Upper respiratory tract infections include laryngitis, nasopharyngitis, ph=
aryngeal abscess, pharyngitis, rhinitis, sinusitis, tonsilitis and upper re=
spiratory tract infection. =C2=A0=C2=A0

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.^9=C2=A0IL-17F has overlapping biology with =
IL-17A and drives inflammation independently of IL-17A.^10,11,12,13,14=C2=
=A0Selective inhibition of IL-17F in addition to IL-17A suppresses inflamma=
tion to a greater extent than IL-17A inhibition alone.^13,14 The safety and=
efficacy 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.^15=C2=A0Psoriasis signs and symptoms can vary but may include re=
d patches of skin covered with silvery scales; dry, cracked skin that may b=
leed; and thickened, pitted or ridged nails.^16

Approximately 125 million people worldwide are living with psoriasis, nearl=
y three percent of the world=E2=80=99s population.^17,18=C2=A0 Unmet needs =
remain in the treatment of psoriasis. A population-based survey identified =
that approximately 30 percent of psoriasis patients reported that their pri=
mary goals of therapy, including keeping symptoms under control, reducing i=
tching and decreasing flaking, were not met with their current treatment.^1=
9=C2=A0Psoriasis has a considerable psychological and quality-of-life impac=
t, potentially affecting work, recreation, relationships, sexual functionin=
g, family and social life.^20

About the BE RADIANT study^1
BE RADIANT is a Phase 3b, randomized, multicenter, double-blind, active com=
parator-controlled, parallel-group study designed to assess the efficacy an=
d safety of bimekizumab compared to secukinumab in adult subjects with mode=
rate to severe chronic plaque psoriasis. BE RADIANT enrolled 743 participan=
ts with psoriasis for at least six months prior to the screening, a baselin=
e PASI score =E2=89=A512, body surface area [BSA] affected by psoriasis =E2=
=89=A510% and IGA score =E2=89=A53.=C2=A0

Patients were randomized to bimekizumab (320 mg every Q4W) or secukinumab (=
300 mg weekly to week 4 and then Q4W).^3 From week 16, bimekizumab-randomiz=
ed patients received treatment dosed Q4W or every 8 weeks (Q8W). The primar=
y endpoint was PASI 100 response at week 16. Key secondary endpoints includ=
ed PASI 100 at week 48 and PASI 75 at week 4.^1 Following the 48-week doubl=
e-blinded period, patients were able to enroll in an ongoing 96-week open-l=
abel extension.

UCB announced top-line findings from BE RADIANT in July 2020.=C2=A0

About the BE SURE study^2

BE SURE was a Phase 3, randomized, double-blind study comparing the efficac=
y and safety of bimekizumab to adalimumab in adult patients with moderate-t=
o-severe chronic plaque psoriasis. The active-controlled initial treatment =
period of 24 weeks was followed by a dose-blind maintenance treatment perio=
d until week 56.=C2=A0

BE SURE enrolled 478 participants with chronic plaque psoriasis for at leas=
t six months prior to screening and with an affected body surface area of =
=E2=89=A510 percent, PASI of =E2=89=A512 and IGA score =E2=89=A5three on a =
five-point scale. The co-primary endpoints of the study were PASI 90 respon=
se and IGA response at week 16.=C2=A0

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=
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deemed forward-looking statements, including estimates of revenues, operati=
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ing statements are not guarantees of future performance and are subject to =
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e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
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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=
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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=
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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=
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ips, joint ventures or licensing collaborations may be subject to differenc=
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rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
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ems.=C2=A0

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=
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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=
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UCB is following the worldwide developments diligently to assess the financ=
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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=
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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=
ction.=C2=A0

For further information, contact UCB:=C2=A0

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,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications
Eimear O'Brien
T + 32.2.559.92.71
eimear.obrien@ucb.com=C2=A0 =C2=A0=C2=A0

References:

1. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus Secukinumab in =
Plaque Psoriasis. NEJM. Available at: www.nejm.org/doi/full/10.1056/NEJMoa2=
102383
2. Warren RB, Blauvelt A, Bagel J et al. Bimekizumab versus Adalimumab in P=
laque Psoriasis. NEJM. Available at: www.nejm.org/doi/full/10.1056/NEJMoa21=
02388=C2=A0
3. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab efficacy and safety ve=
rsus secukinumab in patients with moderate to severe plaque psoriasis: Resu=
lts from a multicenter, randomized, double-blinded, active comparator-contr=
olled phase 3b trial (BE RADIANT). Late-breaking Presentation at AAD VMX 20=
21, April 23-25.
4. Warren R, et al. Bimekizumab efficacy and safety versus adalimumab in pa=
tients with moderate to severe plaque psoriasis: Results from a multicentre=
, randomised, double-blinded active comparator-controlled phase 3 trial (BE=
SURE). Abstract presented at EADV 2020, 29-31 October.
5. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for =
the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy a=
nd safety from a 52-week, multicentre, double-blind, active comparator and =
placebo controlled phase 3 trial. Lancet. =C2=A0 =C2=A0 =C2=A0 =C2=A0Availa=
ble at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)0=
0125-2/fulltext
6. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i=
n moderate to severe plaque psoriasis (BE READY): a multicentre, double-bli=
nd, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. Availa=
ble at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)0=
0126-4/fulltext
7. Papp K, Merola J, Gottlieb A, et al. Dual neutralization of both interle=
ukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: R=
esults from BE ABLE 1, a 12-week randomized, double-blinded, placebo-contro=
lled phase 2b trial. J Am Acad Dermatol. =C2=A0 2018;79(2):277-286.e10.
8. Blauvelt A, Merola JF, Papp KA, et al. Bimekizumab for patients with mod=
erate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomi=
zed, double-blinded, placebo-controlled, phase 2b extension study. J Am Aca=
d Dermatol. 2020;83(5):1367-1374.
9. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual inhibitor of =
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1=
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10. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses =
by IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
11. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot f=
old: structure and activity of a novel cytokine, IL-17F, and implications f=
or receptor binding. EMBO J. 2001;20(19):5332=E2=80=935341.
12. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expres=
sion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syn=
ovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: poss=
ible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther.=
2014;16(4):426.
13. 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 inflamma=
tion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
14. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisatio=
n by bimekizumab in psoriatic arthritis: evidence from preclinical experime=
nts and a randomised placebo-controlled clinical trial that IL-17F contribu=
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15. National Psoriasis Foundation. About Psoriasis. Available at: https://w=
ww.psoriasis.org/about-psoriasis/. Last accessed: March 2021.
16. International Federation of Psoriasis Associations. Available at: www.i=
fpa-pso.com/our-cause//. Last accessed: March 2021.
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