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UCB Media Room: Positive Top-Line Results from BIMZELX®▼(bimekizumab) PSO

INFORMATION REGLEMENTEE


[19/11/2021 | 07:01]
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** Positive Top-Line Results from BIMZELX=C2=AE=E2=96=BC(bimekizumab) Phase=
3 Psoriatic Arthritis Study Demonstrated Significant Improvements in Joint=
and Skin Symptoms
------------------------------------------------------------

=C2=B7 The BE OPTIMAL study met the primary endpoint and all ranked seconda=
ry endpoints with statistical significance
=C2=B7 The study used the high treatment goal of ACR50 as the primary outco=
me measure
=C2=B7 BE OPTIMAL is the first of two Phase 3 trials evaluating the efficac=
y and safety of bimekizumab in adults with active psoriatic arthritis

Brussels, Belgium =E2=80=93 19th November, 2021=E2=80=93 0700 CET - Regulat=
ed Information - Inside Information =E2=80=93 UCB, a global biopharmaceutic=
al company, today announced positive top-line interim analysis results from=
the Phase 3 BE OPTIMAL study assessing the efficacy and safety of BIMZELX^=
=C2=AE (bimekizumab), a dual IL-17A and =C2=A0 IL-17F inhibitor, in the tre=
atment of adults with active psoriatic arthritis, who are biologic disease-=
modifying anti-rheumatic drug na=C3=AFve.^1

BE OPTIMAL met the primary endpoint, demonstrating that significantly more =
patients treated with bimekizumab achieved 50 percent or greater improvemen=
t in signs and symptoms of disease from baseline, compared with placebo, as=
measured by the American College of Rheumatology (ACR) 50 response at week=
16.^1 This Phase 3 study used ACR50 as the primary outcome measure^1 inste=
ad of ACR20, i.e. 50 percent versus 20 percent improvement from baseline.=
=C2=A0

The study also met all ranked secondary endpoints for this interim analysis=
. Among the ranked secondary endpoints, bimekizumab demonstrated significan=
t improvements at week 16 over placebo in physical function, as measured by=
the Health Assessment Questionnaire-Disability Index (HAQ-DI); skin cleara=
nce, as measured by at least a 90 percent improvement in the Psoriasis Area=
and Severity Index (PASI90); and joint radiographic progression, as measur=
ed by the van der Heijde modified Total Sharp Score=C2=A0 (vdHmTSS).1=C2=A0

=E2=80=9CPsoriatic arthritis causes painful debilitating joint and skin inf=
lammation, which impacts mobility and quality of life for patients. At UCB,=
our aim is to support more patients in achieving control of their symptoms=
and we set high treatment goals in BE OPTIMAL. The clinically meaningful i=
mprovements seen in both joint and skin symptoms strengthen our belief that=
bimekizumab can address the unmet needs of patients with psoriatic arthrit=
is,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology S=
olutions and Head of U.S., UCB.

=E2=80=9CToday=E2=80=99s encouraging findings from the BE OPTIMAL study sho=
w the potential of bimekizumab to improve a range of signs and symptoms in =
people with active psoriatic arthritis, and suggest that targeting IL-17F, =
in addition to IL-17A, may be a promising therapeutic approach for this dis=
ease,=E2=80=9D said Professor Iain McInnes, Vice Principal and Head of Coll=
ege, University of Glasgow, Scotland.=C2=A0

The safety profile of bimekizumab was consistent with safety findings seen =
in previous studies with no new observed safety signals.^1 The safety and e=
fficacy of bimekizumab in psoriatic arthritis have not been established, an=
d it is not approved for use in psoriatic arthritis by any regulatory autho=
rity worldwide.

Full results from the BE OPTIMAL study will be presented at an upcoming med=
ical conference and published in a peer-reviewed medical journal.=C2=A0

BE OPTIMAL is one of two Phase 3 studies evaluating bimekizumab in the trea=
tment of active psoriatic arthritis. Results from the second study, evaluat=
ing bimekizumab in the treatment of patients who were inadequate responders=
or intolerant to anti-tumor necrosis factor-=CE=B1 (anti-TNF) therapy, are=
expected soon.^2
=C2=A0=C2=A0=C2=A0 =C2=A0
About BE OPTIMAL
BE OPTIMAL is a randomized, multicenter, double-blind, placebo-controlled, =
non-inferential active reference arm (adalimumab), parallel group, Phase 3 =
study designed to evaluate the efficacy and safety of bimekizumab in the tr=
eatment of adult patients with active psoriatic arthritis, who are biologic=
disease-modifying anti-rheumatic drug na=C3=AFve.^3=C2=A0BE OPTIMAL enroll=
ed 852 participants with disease for at least six months prior to=C2=A0scre=
ening, and a baseline tender joint count (TJC) =E2=89=A5 three out of 68 an=
d swollen joint count (SJC) =E2=89=A5 three out of 66.^3 The study is ongoi=
ng with top-line results from the week 24 interim analysis presented above.=
For additional details on the study, visit BE OPTIMAL on clinicaltrials.go=
v (https://clinicaltrials.gov/ct2/show/NCT03895203) .=C2=A0

About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic syste=
mic inflammatory condition affecting both the joints and skin, with a preva=
lence of 0.05 percent to 0.25 percent of the population, and 6 percent to 4=
1 percent of patients with psoriasis.^4=C2=A0Symptoms include joint pain an=
d stiffness, skin plaques, swollen toes and fingers (dactylitis), and persi=
stent inflammation of the sites where tendons or ligaments insert into the =
bone (enthesitis).^5=C2=A0

About BIMZELX^=C2=AE (bimekizumab)=C2=A0
Bimekizumab is a humanized monoclonal IgG1 antibody that selectively and di=
rectly inhibits both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),=
two key cytokines driving inflammatory processes.^6=C2=A0Selective inhibit=
ion of IL-17F, in addition to IL-17A has been shown to suppress inflammatio=
n to a greater extent than IL-17A inhibition alone.^6,7=C2=A0=C2=A0

About Bimzelx^=C2=AE in the EU/EEA*=C2=A0
In the EU, Bimzelx=C2=AE is indicated for the treatment of moderate to seve=
re plaque psoriasis in adults who are candidates for systemic therapy.^8

*EU/EEA means European Union/European Economic Area

Bimzelx^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat=
ion in Psoriasis=C2=A0

The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).=C2=A0

Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0

Cases of new or exacerbations of inflammatory bowel disease have been repor=
ted with bimekizumab.=C2=A0
Bimekizumab is not recommended in patients with inflammatory bowel disease.=
If a patient develops signs and=C2=A0
symptoms of inflammatory bowel disease or experiences an exacerbation of pr=
e-existing inflammatory bowel disease, bimekizumab should be discontinued a=
nd appropriate medical management should be initiated.=C2=A0

Serious hypersensitivity reactions including anaphylactic reactions have be=
en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o=
ccurs, administration of bimekizumab should be discontinued immediately and=
appropriate therapy initiated.=C2=A0

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the summary of product characteristics in relation to other =
side effects, full safety and prescribing information.=C2=A0

European SmPC date of revision August 2021. https://www.ema.europa.eu/en/do=
cuments/product-information/bimzelx-epar-product-information_en.pdf

Last accessed: November 2021.

=E2=96=BC=C2=A0 This medicinal product is subject to additional monitoring.=
This will allow quick identification of new safety information. Healthcare=
professionals are asked to report any suspected adverse reactions=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 more than 8=C2=A0000 peop=
le in approximately 40 countries, the company generated revenue of =E2=82=
=AC5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). F=
ollow us on 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=
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=C2=A0reproduced in c=
omputer models, cell culture systems or animal models. The length of the ti=
ming to complete clinical trials and to get regulatory approval for product=
marketing has varied in the past and UCB expects similar unpredictability =
going forward. Products or potential products which are the subject of part=
nerships, joint ventures or licensing collaborations may be subject to diff=
erences disputes between the partners or may prove to be not as safe, effec=
tive or commercially successful as UCB may have believed at the start of su=
ch partnership. UCB=E2=80=99 efforts to acquire other products or companies=
and to integrate the operations of such acquired companies may not be as s=
uccessful as UCB may have believed at the moment of acquisition. Also, UCB =
or others could discover safety, side effects or manufacturing problems wit=
h its products and/or devices after they are marketed. The discovery of sig=
nificant problems with a product similar to one of UCB=E2=80=99s products t=
hat implicate an entire class of products may have a material adverse effec=
t on sales of the entire class of affected products. Moreover, sales may be=
impacted by international and domestic trends toward managed care and heal=
th care cost containment, including pricing pressure, political and public =
scrutiny, customer and prescriber patterns or practices, and the reimbursem=
ent policies imposed by third-party payers as well as legislation affecting=
biopharmaceutical pricing and reimbursement activities and outcomes. Final=
ly, a breakdown, cyberattack or information security breach could compromis=
e the confidentiality, integrity and availability of UCB=E2=80=99s data and=
systems.=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=
tional or approved products described in this press release will=C2=A0
be submitted or approved for sale or for any additional indications or labe=
lling in any market, or at any particular time, nor can there be any guaran=
tee that such products will be or will continue to be commercially successf=
ul in the future.

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=
ction.=C2=A0

For further information, contact UCB:=C2=A0

Brand Communications
Eimear O=E2=80=99Brien,=C2=A0
Brand Communications, UCB
T + 32.2.559.92.71
eimear.obrien@ucb.com

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

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

References

1. Data on file. UCB. November 2021.
2. Clinical Trials.gov. A Study to Evaluate the Efficacy and Safety of Bime=
kizumab in the Treatment of Subjects with Active =C2=A0 Psoriatic Arthritis=
(BE COMPLETE). Available at: https://clinicaltrials.gov/ct2/show/NCT038965=
81 =C2=A0Last Accessed: November 2021
3. ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizum=
ab in the Treatment of Subjects With Active Psoriatic Arthritis (BE OPTIMAL=
). Available at: https://clinicaltrials.gov/ct2/show/NCT03895203. Last acce=
ssed: November 2021.=C2=A0
4. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Cli=
n North Am. 2015;41(4):545=E2=80=93568.=C2=A0
5. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the di=
agnosis and pharmacologic treatment of psoriatic arthritis in patients with=
psoriasis. Drugs. 2014;74:423-441.
6. 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=
001.
7. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation=
by bimekizumab in psoriatic arthritis: evidence from preclinical experimen=
ts and a randomised placebo-controlled clinical trial that IL-17F contribut=
es to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
8. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Augu=
st 2021. Last accessed: November 2021. https://www.ema.europa.eu/en/documen=
ts/product-information/bimzelx-epar-product-information_en.pdf

GenericFile
UCB press release bimekizumab PSO Nov 19 2021 ENG (https://mb.cision.com/Pu=
blic/18595/3456820/a57a53dce0a5907f.pdf)

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