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** Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Mea=
ningful, Deep and Maintained Response over 48 Weeks
------------------------------------------------------------
=C2=B7 Patients treated with investigational bimekizumab, an IL-17A and IL-=
17F inhibitor, achieved statistically significant and clinically meaningful=
improvements over placebo in signs and symptoms of hidradenitis suppurativ=
a at week 16, as measured by HiSCR50=C2=A0
=C2=B7 Bimekizumab demonstrated deep levels of clinical response over place=
bo at week 16, as measured by HiSCR75, a key secondary endpoint
=C2=B7 Patients treated with bimekizumab experienced improved health-relate=
d quality of life over placebo at week 16, a key secondary endpoint
=C2=B7 Clinical responses were maintained with continuous bimekizumab treat=
ment =E2=80=93 over 75 percent of patients achieved HiSCR50, and over 55 pe=
rcent achieved HiSCR75, at week 48=C2=B1=C2=A0
Brussels (Belgium) 18th March 2023 =E2=80=93 19:10 (CET) =E2=80=93 UCB, a g=
lobal biopharmaceutical company, today announced detailed positive results =
from two Phase 3 studies (BE HEARD I and BE HEARD II) evaluating the effica=
cy and safety of bimekizumab in the treatment of adults with moderate to se=
vere hidradenitis suppurativa (HS).^1 Data from the two studies showed that=
bimekizumab achieved statistically significant and consistent clinically m=
eaningful improvements over placebo in the signs and symptoms of HS at week=
16, which were maintained to week 48.^1,=C2=B1 Clinical responses with bim=
ekizumab were observed from the first dose with some patients achieving HiS=
CR50 at week four.^1 These new data were presented today at a late-breaking=
platform presentation at the 2023 American Academy of Dermatology (AAD) An=
nual Meeting in New Orleans, U.S., 17th-22nd March.=C2=A0
=E2=80=9CHidradenitis Suppurativa is a chronic, debilitating inflammatory s=
kin disease for which only one approved treatment is available today,=E2=80=
=9D said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deacones=
s Medical Center and Professor of Dermatology, Harvard Medical School, Bost=
on, MA, U.S. =E2=80=9CTreating moderate to severe cases with bimekizumab ha=
s shown promising results in phase 3 patient trials, with sustained improve=
ment after one year.=E2=80=9D =C2=A0
The two studies (n=3D505 in BE HEARD I; n=3D509 in BE HEARD II) evaluated t=
wo dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 mg ev=
ery four weeks [Q4W]) versus placebo over the 16-week initial and the 32-we=
ek maintenance treatment periods.^1 Data presented at AAD 2023 show that:
=C2=B7 A significantly higher proportion of patients treated with bimekizum=
ab (Q2W) achieved HiSCR50, the primary endpoint, at week 16 vs. placebo in =
BE HEARD I and BE HEARD II (47.8 percent vs. 28.7 percent [p=3D0.006] and 5=
2.0 percent vs. 32.2 percent [p=3D0.003], respectively).^1
=C2=B7 A greater proportion of patients treated with bimekizumab (Q4W) achi=
eved HiSCR50 at week 16 than placebo in BE HEARD I and BE HEARD II, with st=
atistical significance achieved in BE HEARD II (45.3 percent vs. 28.7 perce=
nt [p=3D0.030] and 53.8 percent vs. 32.2 percent [p=3D0.004], respectively)=
.^1=C2=A0
=C2=B7 Patients treated with bimekizumab achieved deep levels of clinical r=
esponse with a greater proportion achieving HiSCR75, a key secondary endpoi=
nt, at week 16 than placebo, with statistical significance in BE HEARD II w=
ith both dose regimens and for Q2W in BE HEARD I.^1
=C2=B7 Patients treated with bimekizumab experienced improved health-relate=
d quality of life (change from baseline in the dermatology life quality ind=
ex) compared with placebo at week 16 (BE HEARD I and BE HEARD II, Q2W and Q=
4W).^1=C2=A0
=C2=B7 Clinical responses (HiSCR50 and HiSCR75) were maintained with contin=
uous bimekizumab treatment =E2=80=93 over 75 percent of patients achieved H=
iSCR50, and over 55 percent achieved HiSCR75 at week 48 (observed case anal=
ysis; BE HEARD I and BE HEARD II, Q2W and Q4W).^1=C2=A0
=E2=80=9CToday, at the largest dermatology meeting of the year, we unveiled=
48-week data from our Phase 3 bimekizumab program in hidradenitis suppurat=
iva. Results from the Phase 3 program highlight the meaningful clinical out=
comes achieved by targeting IL-17F in addition to IL-17A,=E2=80=9D said Emm=
anuel Caeymaex, Executive Vice President, Immunology Solutions and Head of =
U.S., UCB. =E2=80=9CWe are now focused on the next steps with global regula=
tory filings for bimekizumab in hidradenitis suppurativa planned for later =
this year.=E2=80=9D=C2=A0
The safety profile of bimekizumab across BE HEARD I and BE HEARD II was con=
sistent with previous studies with no new safety signals observed.^1 The mo=
st common (frequency of >5 percent) treatment emergent adverse events on bi=
mekizumab over 16 weeks were hidradenitis (7.2 percent in BE HEARD I and 8.=
8 percent in BE HEARD II), oral candidiasis (4.4 percent in BE HEARD I and =
6.7 percent in BE HEARD II), headache (7.0 percent in BE HEARD I and 5.8 in=
BE HEARD II) and diarrhea (7.0 percent in BE HEARD I and 5.3 percent in BE=
HEARD II).^1=C2=A0
UCB expects to submit global regulatory applications for bimekizumab in mod=
erate to severe HS starting in Q3 2023. =C2=A0
In the U.S., the efficacy and safety of bimekizumab have not been establish=
ed for any indication and it is not approved by the U.S. Food and Drug Admi=
nistration. In the European Union and Great Britain, bimekizumab is approve=
d for the treatment of moderate to severe plaque psoriasis in adults who ar=
e candidates for systemic therapy.^2,3 UCB is investigating bimekizumab in =
HS. The efficacy and safety of bimekizumab in HS have not been established,=
and it is not approved for use in this indication by any regulatory author=
ity worldwide.
Notes to editors:
=C2=B1 Observed case analysis.
About BE HEARD I and BE HEARD II
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 (=
HS). BE HEARD I enrolled 505 participants with a diagnosis of moderate to s=
evere HS.^1
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 HS. BE HEARD II enrolled =
509 participants with a diagnosis of moderate to severe HS.^1=C2=A0
BE HEARD I and II comprised double-blind 16-week initial and 32-week mainte=
nance treatment periods. Participants with moderate to severe HS were rando=
mized 2:2:2:1 to (initial/maintenance) bimekizumab 320mg every 2 weeks (Q2W=
)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W, placebo/bimekizumab Q2W. U=
ntil week 16, bimekizumab Q2W/Q2W and bimekizumab Q2W/Q4W were combined to =
bimekizumab Q2W.^1=C2=A0
The primary endpoint in both studies was HiSCR50 at week 16.^1 A key second=
ary endpoint was HiSCR75 at week 16.^1 HiSCR50 and HiSCR75 are defined as a=
t least either a 50 or 75 percent reduction from baseline in the total absc=
ess and inflammatory nodule count, with no increase from baseline in absces=
s or draining tunnel count.^4,5=C2=A0
For additional details on the study, visit BE HEARD I (https://clinicaltria=
ls.gov/ct2/show/NCT04242446?term=3Dbe+heard&draw=3D2&rank=3D1) on clinicalt=
rials.gov. For additional details on the study, visit BE HEARD II (https://=
clinicaltrials.gov/ct2/show/NCT04242498) on clinicaltrials.gov.^4,5=C2=A0
About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit=
ating inflammatory skin disease.^6,7=C2=A0 The main symptoms are nodules, a=
bscesses, and pus-discharging fistulas (channels leading out of the skin) w=
hich typically occur in the armpits, groin and buttocks.^6,7 People with HS=
experience flare-ups of the disease as well as severe pain, which can have=
a major impact on quality of life.^6,7=C2=A0
HS develops in early adulthood, affects approximately one percent of the po=
pulation in most studied countries.^6,7 Approximately one third of people w=
ith HS have a family history of HS, and lifestyle factors such as smoking a=
nd obesity can also play a crucial role in the clinical course of HS.^8
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.^9 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.^6,8
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.^2,10=C2=A0 In August 20=
21, bimekizumab was first approved in the European Union (EU)/European Econ=
omic Area (EEA) and in Great Britain, for the treatment of moderate to seve=
re plaque psoriasis in adults who are candidates for systemic therapy.^2,3=
=C2=A0The label information may differ in other countries where approved. P=
lease check local prescribing information. In the U.S., the efficacy and sa=
fety of bimekizumab have not been established for any indication and it is =
not approved by the U.S. Food and Drug Administration (FDA).
About BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) in the EU/EEA
In the EU/EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate to=
severe plaque psoriasis in adults who are candidates for systemic therapy.=
^2=C2=A0
BIMZELX^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat=
ion in Psoriasis
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. 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. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld 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: March 2023.
=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=
5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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=
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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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stems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
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UCB is providing this information, including forward-looking statements, on=
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References
1. Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with m=
oderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety fro=
m BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlle=
d, multicenter studies. Late-Breaking Platform Presentation at the 2023 Ame=
rican Academy of Dermatology Annual Meeting.
2. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Marc=
h 2022. Available at:=C2=A0https://www.ema.europa.eu/en/documents/product-i=
nformation/bimzelx-epar-product-information_en.pdf . Last accessed: March 2=
023.
3. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref . Last a=
ccessed: March 2023.
4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati=
va (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT04242=
446?term=3Dbe+heard&draw=3D2&rank=3D1. Last accessed: March 2023=C2=A0
5. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Study Participants With Moderate to Severe Hidradenitis Suppurati=
va (BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT0424=
2498 Last accessed: March 2023
6. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 20=
12;366(2):158-164.
7. Sabat R, Jemec GBE, Matusiak L. et al. Hidradenitis suppurativa. Nat Rev=
Dis Primers. 2020;6:18.
8. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hid=
radenitis Suppurativa and Its Effect on Patients and Healthcare System. Der=
matology. 2020;236:421=E2=80=93430.
9. Koumaki D, Ourania E, Bozi E, et al. Perspectives On Perceived Stigma An=
d Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Invest=
ig Dermatol. 2019;12:785=E2=80=93790.
10. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, 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-=
1001.
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