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UCB Media Room - Interim results from bimekizumab trial

INFORMATION REGLEMENTEE


[07/08/2021 | 20:07]
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** New Two-Year Data Showed Bimekizumab Maintained High Levels of Skin Clea=
rance in Patients with Moderate to Severe Plaque Psoriasis
------------------------------------------------------------

=C2=B7 Interim results from the BE BRIGHT open-label extension trial with b=
imekizumab, an investigational IL-17A and IL-17F inhibitor, were presented =
today at the 2021 AAD Summer Meeting
=C2=B7 Data showed that over nine out of 10 patients who achieved clear or =
almost clear skin (IGA 0/1) after 16 weeks of bimekizumab treatment maintai=
ned these responses through to two years with continuous maintenance dosing
=C2=B7 Over eight out of 10 patients who achieved complete skin clearance (=
PASI 100) at week 16 maintained PASI 100 responses through to two years of =
treatment with continuous maintenance dosing

Brussels, Belgium and Atlanta, Ga. =E2=80=93 August 7th, 2021 =E2=80=93 20:=
00 CEST/14:00 EST =E2=80=93 UCB, a global biopharmaceutical company, announ=
ced today new interim data from BE BRIGHT, an open-label extension (OLE) tr=
ial to assess the long-term safety, tolerability and efficacy of bimekizuma=
b, an investigational IL-17A and IL-17F inhibitor, in adults with moderate =
to severe plaque psoriasis.^[i],[ii] These results were presented today dur=
ing a platform presentation at the 2021 American Academy of Dermatology (AA=
D) Summer Meeting, Tampa, Florida, U.S.

Data presented showed that the majority of patients who achieved complete o=
r near complete skin clearance after 16 weeks of bimekizumab treatment main=
tained these responses through to two years with continuous maintenance dos=
ing, every four weeks (Q4W) or every eight weeks (Q8W).^[i] The efficacy an=
d safety of bimekizumab have not been established and it is not approved by=
any regulatory authority worldwide.

=E2=80=9CThese interim results from the BE BRIGHT study highlight the poten=
tial of bimekizumab to provide lasting skin clearance to adults living with=
moderate to severe plaque psoriasis,=E2=80=9D said Mark Lebwohl, MD, Dean =
for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Cha=
irman emeritus, Kimberly and Eric J. Waldman Department of Dermatology and =
Presenting Author of the data at the AAD Summer Meeting. =E2=80=9CThese dat=
a are meaningful for the dermatology community and further add to the clini=
cal evidence we have from the bimekizumab Phase 3 clinical program.=E2=80=
=9D

=E2=80=9CGiven the chronic nature of psoriasis, physicians and patients val=
ue treatment options that can offer long-term disease control,=E2=80=9D sai=
d Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Hea=
d of U.S., UCB. =E2=80=9CWe are pleased to share the first presentation of =
bimekizumab data from the BE BRIGHT study highlighting the potential of bim=
ekizumab to provide complete skin clearance that can last through to two ye=
ars in adult patients with moderate to severe plaque psoriasis.=E2=80=9D

Results shared today report on the maintenance of the Investigator=E2=80=99=
s Global Assessment (IGA) of Clear or Almost Clear skin (IGA 0/1), Body Sur=
face Area (BSA) =E2=89=A41%, and Psoriasis Area and Severity Index (PASI) 1=
00 through to two years of bimekizumab treatment.^[i]=C2=A0Analyses include=
d 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.^[i]

Initially, 989 patients were randomized to bimekizumab Q4W. At week 16, 87.=
5 percent achieved IGA 0/1, 74.9 percent achieved BSA =E2=89=A41% 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).^[i=
]=C2=A0Similarly, among week 16 BSA =E2=89=A41% responders, over nine out o=
f 10 patients maintained BSA =E2=89=A41% to week 48 in the OLE trial (90.7 =
and 92.5 percent with continuous Q4W and Q8W maintenance dosing, respective=
ly). Over eight out of 10 patients who achieved complete skin clearance (PA=
SI 100) at week 16 maintained response to week 48 in the OLE trial (80.7 an=
d 86.1 percent with continuous Q4W and Q8W maintenance dosing, respectively=
).^[i]

In BE READY, BE VIVID and BE SURE, the most frequently reported treatment-e=
mergent adverse events in bimekizumab-treated patients were nasopharyngitis=
, oral candidiasis, and upper respiratory tract infection.^[iii],[iv],[v],[=
vi]

Bimekizumab is currently under review by the U.S. Food and Drug Administrat=
ion (FDA) for the treatment of moderate to severe plaque psoriasis in adult=
s. On June 25th, 2021, the European Medicines Agency=E2=80=99s Committee fo=
r Medicinal Products for Human Use (CHMP) adopted a positive opinion recomm=
ending granting a marketing authorization for bimekizumab for the treatment=
of moderate to severe plaque psoriasis in adults who are candidates for sy=
stemic therapy. The final decision of the European Commission on marketing =
authorization is expected within approximately two months of the CHMP opini=
on.

** Notes to Editors:
------------------------------------------------------------

** About BE BRIGHT^[ii]
------------------------------------------------------------

BE BRIGHT (NCT03598790) is an ongoing, multicentre, open-label extension st=
udy assessing the long-term safety, tolerability and efficacy of bimekizuma=
b 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 b=
e found at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03598=
790) .

** About bimekizumab
------------------------------------------------------------

Bimekizumab is an investigational humanized IgG1 monoclonal antibody that i=
s designed to selectively and directly inhibit both IL-17A and IL-17F, two =
key cytokines driving inflammatory processes.^[iv],[v],[vi] Selective inhib=
ition of IL-17F in addition to IL-17A has been shown to suppress inflammati=
on to a greater extent than IL-17A inhibition alone.^[iv],[v],[vi]
The efficacy and safety of bimekizumab have not been established and it is =
not approved by any regulatory authority worldwide.

** About Psoriasis
------------------------------------------------------------

Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin.^[vii] This skin condition affects men and women of all ages =
and ethnicities.^[vii] Psoriasis signs and symptoms can vary but may includ=
e red patches of skin covered with silvery scales; dry, cracked skin that m=
ay bleed; and thickened, pitted or ridged nails.^[viii] Psoriasis also has =
a considerable psychological and quality-of-life impact, potentially affect=
ing work, recreation, relationships, sexual functioning, family and social =
life.^[ix]

Unmet needs remain in the treatment of psoriasis. A population-based survey=
identified that approximately one in three psoriasis patients reported tha=
t their primary goals of therapy, including keeping symptoms under control,=
reducing itching and decreasing flaking, were not met with their current t=
reatment.^[x]

** About UCB
------------------------------------------------------------

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=
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to complete clinical trials and to get regulatory approval for product mark=
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to integrate the operations of such acquired companies may not be as succes=
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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=
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UCB is following the worldwide developments diligently to assess the financ=
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m the actual results or to report or reflect any change in its forward-look=
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Additionally, information contained in this document shall not constitute a=
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For further information, contact UCB:

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

Investor Relations
Antje Witte,
Investor Relations, UCB
T +32.2.559.94.14
antje.witte@ucb.com

Brand Communications
Eimear O=E2=80=99Brien,
Brand Communications, UCB
T +32.2.559.92.71
eimear.obrien@ucb.com

[i]=C2=A0=C2=A0 Strober B, Asahina A, Mrowietz U, et al. Bimekizumab respon=
se 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

[ii]=C2=A0=C2=A0ClinicalTrials.gov. Available at https://clinicaltrials.gov=
/ct2/show/NCT03598790 Last accessed: August 2021.

[iii]=C2=A0 UCB Data on File, July 2021.

[iv]=C2=A0 Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinu=
mab for the treatment of moderate to severe plaque psoriasis (BE=C2=A0VIVID=
): efficacy and safety from a 52-week, multicentre, double-blind, active co=
mparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-=
498.

[v]=C2=A0 Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and s=
afety in moderate to severe plaque psoriasis (BE READY): a multicentre, dou=
ble-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet.=
2021;397(10273):475-486.

[vi]=C2=A0 Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalim=
umab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.

[vii]=C2=A0 National Psoriasis Foundation. About Psoriasis. Available at: h=
ttps://www.psoriasis.org/about-psoriasis/. Last accessed: August 2021.

[viii] =C2=A0International Federation of Psoriasis Associations. Available =
at: https://ifpa-pso.com/our-cause. Last accessed: August 2021.

[ix]=C2=A0 Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology.=
Dermatol Ther (Heidelb). 2013;3(2):117-130.

[x]=C2=A0 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.

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