Home   About this service   Get the news  
+32 2 743 34 03

UCB [BE0003739530 / UCB]

UCB Media Room - Interim results from bimekizumab trial


[07/08/2021 | 20:07]

** 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=

=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=

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],[=

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=

** 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 =

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=

** 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=
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=
ed legal, arbitration, political, regulatory or clinical results or practic=
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=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
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=
iny, customer and prescriber patterns or practices, and the reimbursement p=
olicies imposed by third-party payers as well as legislation affecting biop=
harmaceutical pricing and reimbursement activities and outcomes. Finally, a=
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.

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, contact UCB:

Corporate Communications
Laurent Schots,
Media Relations, UCB
T +32.2.559.92.64

Investor Relations
Antje Witte,
Investor Relations, UCB
T +32.2.559.94.14

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

[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 =

[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-=

[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.=

[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.

GL-N-BK-PSO-2100219 (https://mb.cision.com/Public/18595/3392626/bfbd8d17c22=

If you would rather not receive future communications from UCB SA, please g=
o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x78749x1x6868579x24000=
UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium