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** UCB Announces Positive Phase 3 Studies for Bimekizumab in Hidradenitis S=
uppurativa
------------------------------------------------------------
=C2=B7 Top-line results show that the two Phase 3 studies, BE HEARD I and B=
E HEARD II, met their primary and key secondary endpoints with statistical =
significance and consistent clinical relevance=C2=A0
=C2=B7 First Phase 3 evidence to suggest that targeting IL-17F in addition =
to IL-17A may be a promising treatment approach in adults with moderate to =
severe hidradenitis suppurativa=C2=A0
=C2=B7 Results from these two studies will form the basis of global regulat=
ory applications for bimekizumab in hidradenitis suppurativa starting in Q3=
2023 =C2=A0
Brussels (Belgium), 9th December 2022 =E2=80=93 07:00 (CET) =E2=80=93 Regul=
ated information =E2=80=93 Inside information =E2=80=93 UCB, a global bioph=
armaceutical company, today announced positive top-line results from two Ph=
ase 3 studies, BE HEARD I and BE HEARD II, evaluating the efficacy and safe=
ty of bimekizumab in adults with moderate to severe hidradenitis suppurativ=
a.^1,2 The positive results from these two studies will form the basis of g=
lobal regulatory license applications for bimekizumab in hidradenitis suppu=
rativa starting in Q3 2023. The safety and efficacy of bimekizumab in hidra=
denitis suppurativa have not been established, and it is not approved for u=
se in hidradenitis suppurativa by any regulatory authority worldwide.=C2=A0
=E2=80=9CWe are excited to announce positive pivotal Phase 3 outcomes in mo=
derate to severe hidradenitis suppurativa which support our strong belief i=
n bimekizumab and provide the first Phase 3 evidence suggesting that target=
ing IL-17F in addition to IL-17A may be a promising treatment approach. We =
look forward to bringing bimekizumab to people living with this chronic inf=
lammatory disease as soon as possible,=E2=80=9D said Emmanuel Caeymaex, Exe=
cutive Vice President, Immunology Solutions and Head of U.S., UCB.=C2=A0
Across the two studies, bimekizumab met the primary endpoint, demonstrating=
statistically significant and consistent clinically meaningful improvement=
s over placebo in the proportion of patients who achieved the Hidradenitis =
Suppurativa Clinical Response (HiSCR50) at week 16.^1,2 Bimekizumab demonst=
rated depth of response with statistically significant improvements at week=
16 over placebo in the percentage of patients achieving HiSCR75, a key sec=
ondary endpoint in both studies.^1,2 HiSCR50 and HiSCR75 are defined as at =
least either a 50 or 75 percent reduction from baseline in the total absces=
s and inflammatory nodule count, with no increase from baseline in abscess =
or draining tunnel count.^3,4 The safety profile of bimekizumab in both stu=
dies was consistent with previously reported studies with no new observed s=
afety signals.^1,2=C2=A0
=E2=80=9CHidradenitis suppurativa is a chronic, painful and debilitating in=
flammatory skin disease that impacts patients=E2=80=99 physical, psychologi=
cal, and social well-being. This reduced quality of life is compounded by t=
he limited treatment options currently available,=E2=80=9D said Professor G=
regor Jemec, MD, Ph.D., Chairman, Department of Dermatology Zeeland Univers=
ity, Roskilde, Denmark. =E2=80=9CThe positive top-line clinical outcomes fr=
om BE HEARD I and BE HEARD II are promising and demonstrate the value that =
bimekizumab can potentially bring to the hidradenitis suppurativa community=
.=E2=80=9D
Detailed results from BE HEARD I and BE HEARD II will be presented at an up=
coming scientific meeting and published in a peer-reviewed medical journal.
Notes to editors:
About BE HEARD I
BE HEARD I is a randomized, double-blind, placebo-controlled, parallel grou=
p, multicenter, Phase 3 study designed to evaluate the efficacy and safety =
of bimekizumab in adults with moderate to severe hidradenitis suppurativa.^=
3 BE HEARD I enrolled 505 participants with a diagnosis of moderate to seve=
re hidradenitis suppurativa.^3 For additional details on the study, visit B=
E HEARD I (https://clinicaltrials.gov/ct2/show/NCT04242446?term=3Dbe+heard&=
draw=3D2&rank=3D1) on clinicaltrials.gov.^3=C2=A0
About BE HEARD II
BE HEARD II is a randomized, double-blind, placebo-controlled, parallel gro=
up, multicenter, Phase 3 study designed to evaluate the efficacy and safety=
of bimekizumab in adults with moderate to severe hidradenitis suppurativa.=
^4 BE HEARD II enrolled 509 participants with a diagnosis of moderate to se=
vere hidradenitis suppurativa.^4 For additional details on the study, visit=
BE HEARD II (https://clinicaltrials.gov/ct2/show/NCT04242498) on clinicalt=
rials.gov.^4=C2=A0
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit=
ating inflammatory skin disease.5,6 The main symptoms are nodules, abscesse=
s, and pus-discharging fistulas (channels leading out of the skin) which ty=
pically occur in the armpits, groin and buttocks.^5,6 People with HS experi=
ence flare-ups of the disease as well as severe pain, which can have a majo=
r impact on quality of life.^5,6=C2=A0
HS develops in early adulthood, affects approximately one percent of the po=
pulation in most studied countries and is three times more common in women =
than in men.^5,6 Approximately one third of people with HS have a family hi=
story of HS, and lifestyle factors such as smoking and obesity can also pla=
y a crucial role in the clinical course of HS.^7
The symptoms of pain, discharge and scarring are not only a physical burden=
. People with HS also experience stigma: worrying about or directly experie=
ncing negative attitudes and reactions from society in response to their sy=
mptoms.^8 These feelings can lead to embarrassment, social isolation, low s=
elf-esteem and sexual life impairment, and impact all areas of life, includ=
ing interpersonal relationships, education and work.^5,7
About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^9
In August 2021, bimekizumab was approved in the European Union (EU)/Europea=
n Economic Area (EEA) and in Great Britain, for the treatment of moderate t=
o severe plaque psoriasis in adults who are candidates for systemic therapy=
.^10,11 The label information may differ in other countries. Please check l=
ocal prescribing information.
BIMZELX^=C2=AE=C2=A0=E2=96=BC (bimekizumab) EU/EEA Important Safety Informa=
tion in Psoriasis
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5 percent) (most frequently nasopharyngiti=
s) and oral candidiasis (7.3 percent). Common adverse reactions (=E2=89=A51=
/100 to <1/10) were oral candidiasis, tinea infections, ear infections, her=
pes simplex infections, oropharyngeal candidiasis, gastroenteritis, follicu=
litis, headache, dermatitis and eczema, acne, injection site reactions, fat=
igue. Elderly may be more likely to experience certain adverse reactions su=
ch as oral candidiasis, 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. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al 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. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
EU summary of product characteristics date of revision December 2022
Last accessed: December 2022.
=E2=96=BC=C2=A0This 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
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=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 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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UCB is providing this information, including forward-looking statements, on=
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References
1. BE HEARD I Phase 3 Study, UCB Data on file, December 2022.
2. BE HEARD II Phase 3 Study, UCB Data on file, December 2022.
3. ClinicalTrials.gov. A study to test the efficacy and safety of bimekizum=
ab in study participants with moderate to severe hidradenitis suppurativa (=
BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242446 =
(https://clinicaltrials.gov/ct2/show/NCT04242446.) . Last accessed: Decembe=
r 2022.
4. ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizum=
ab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (=
BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT04242498=
. Last accessed: December 2022.
5. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 20=
12;366(2):158-164.=C2=A0
6. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev=
Dis Primers. 2020;6(1);18
7. Kokolakis G, Wolk K, Schneider-Burrus S et al. Delayed Diagnosis of Hidr=
adenitis Suppurativa and Its Effect on Patients and Healthcare System. Derm=
atology. 2020;236(5):421=E2=80=93430.
8. Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma =
And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Inve=
stig Dermatol 2019:12:785=E2=80=93790.
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=
001.=C2=A0
10. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Dec=
ember 2022.=C2=A0https://www.ema.europa.eu/en/documents/product-information=
/bimzelx-epar-product-information_en.pdf. Last accessed: December 2022. =C2=
=A0
11. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics, May=
2022.=C2=A0https://www.medicines.org.uk/emc/product/12834; https://www.med=
icines.org.uk/emc/product/12833. Last accessed: December 2022.
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