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** UCB=E2=80=99s Rozanolixizumab and Zilucoplan Phase 3 Generalized Myasthe=
nia Gravis studies published in prestigious The Lancet Neurology Journal
------------------------------------------------------------
=C2=B7 MycarinG study publication reports the clinically meaningful and sta=
tistically significant effects of rozanolixizumab across key endpoints in a=
dult patients with acetylcholine receptor autoantibody positive (AChR-Ab+) =
or muscle-specific tyrosine kinase (MuSK-Ab+) autoantibody positive gMG, in=
the largest study in patients with gMG to date.
=C2=B7 RAISE publication describes clinically meaningful and statistically =
significant improvements in MG-specific efficacy outcomes, as well as a fav=
orable safety profile, for zilucoplan, the first C5 complement inhibitor to=
be self-administered at home by adult patients with AChR-Ab+ gMG. =C2=A0
=C2=B7 Rozanolixizumab and zilucoplan are investigational therapies current=
ly under regulatory review in the U.S., Europe and Japan.=C2=A0
Brussels (Belgium) 13 April 2023 =E2=80=93 07:00 AM (CET) =E2=80=93 UCB, a =
global biopharmaceutical company, today announced that The Lancet Neurology=
has published data from the Phase 3 MycarinG study evaluating the efficacy=
and safety of rozanolixizumab in adult patients with acetylcholine recepto=
r autoantibody-positive (AChR-Ab+) or muscle-specific tyrosine kinase autoa=
ntibody-positive (MuSK-Ab+) generalized myasthenia gravis (gMG) and the Pha=
se 3 RAISE study evaluating the efficacy and safety of zilucoplan in adult =
patients with mild to severe AChR-Ab+ gMG.^1,2
UCB is investigating both therapies as part of a broad offering to treat ad=
ult patients living with gMG throughout their treatment journey; each has a=
n individual mechanism of action targeting the underlying disease pathology=
that causes gMG.=C2=A0
The safety and efficacy of rozanolixizumab and zilucoplan have not been est=
ablished and neither treatment is approved for use in any indication by any=
regulatory authority worldwide.
=E2=80=9CThere is an ongoing need for well-tolerated, targeted treatment op=
tions to improve the quality of life of people living with gMG. Many of the=
current treatment options only offer symptomatic relief which results in a=
treatment burden in addition to the already substantial disease burden,=E2=
=80=9C said Iris Loew-Friedrich, Executive Vice-President and Chief Medical=
Officer at UCB. =E2=80=9CThese papers published in The Lancet Neurology fu=
rther reinforce the potential of rozanolixizumab and zilucoplan =E2=80=93 w=
ith their different MOAs =E2=80=93 to provide targeted treatment options to=
patients to help them manage fluctuating and unpredictable symptoms both a=
t home and in a healthcare setting.=E2=80=9D
In the MycarinG study^1 (n=3D200) - the largest gMG population Phase 3 stud=
y published to date =E2=80=93 in adult patients with AChR-Ab+ or MuSK-Ab+ g=
MG, rozanolixizumab demonstrated statistically significant and clinically m=
eaningful improvements in MG-specific outcomes in patients with MuSK-Ab+ or=
AChR-Ab+ gMG, that were consistent with prior published results. Reduction=
s in MG-ADL score from baseline to day 43 were greater in the rozanolixizum=
ab 7 mg/kg group (least-squares mean change =E2=80=933=C2=B737 [SE 0=C2=B74=
9]) and in the rozanolixizumab 10 mg/kg group (=E2=80=933=C2=B740 [0=C2=B74=
9]) than with placebo (=E2=80=930=C2=B778 [0=C2=B749]; for 7 mg/kg, least-s=
quares mean difference =E2=88=922=C2=B759 [95% CI =E2=88=924=C2=B709 to =E2=
=88=921=C2=B725], p<0=C2=B70001; for 10 mg/kg, =E2=88=922=C2=B762 [=E2=88=
=923=C2=B799 to =E2=88=921=C2=B716], p<0=C2=B70001). In the MuSK-Ab+ specif=
ic subgroup, improvement in MG-ADL was =E2=80=937.28 (7mg/kg; n=3D5), =E2=
=80=934.16 (10mg/kg; n=3D8), and 2.28 (placebo; n=3D8). In the AChR-Ab+ spe=
cific subgroup, improvement in MG-ADL was =E2=80=933.03 (7mg/kg; n=3D60), =
=E2=80=933.36, (10mg/kg; n=3D60), and =E2=80=931.10 (placebo; n=3D59).=C2=
=A0
Both rozanolixizumab doses were generally well tolerated with similar occur=
rences of TEAEs between both doses. The most frequently reported TEAEs were=
headache, diarrhea, and pyrexia. A higher incidence of headache was report=
ed in the rozanolixizumab groups versus placebo, with most cases mild to mo=
derate and severe cases generally managed with non-opioid analgesics. Treat=
ment discontinuation rates due to TEAEs were low.=C2=A0
Importantly, the MycarinG study included Patient-Reported Outcomes (PROs) m=
easures as secondary endpoints. The novel Myasthenia Gravis Symptoms PRO (M=
GS-PRO) =E2=80=93 a measure used to assess symptom severity and impact of M=
G on patient lives, including physical fatigue which is not covered in othe=
r MG clinical outcome assessments =E2=80=93 demonstrated statistically sign=
ificant results vs placebo.
=E2=80=9CThe findings from the MycarinG study support the mechanism of acti=
on of neonatal Fc receptor inhibition and the potential for rozanolixizumab=
in adult patients with acetylcholine receptor autoantibody positive (AChR-=
Ab+) or muscle-specific tyrosine kinase (MuSK-Ab+) autoantibody positive ge=
neralized myasthenia gravis,=E2=80=9D explained =C2=A0Professor Vera Bril, =
Professor of Medicine (Neurology), University of Toronto, Director of the N=
euromuscular Section, Division of Neurology, University of Toronto and Univ=
ersity Health Network, Toronto, and lead investigator of the MycarinG study=
. =E2=80=9CRozanolixizumab showed clinically meaningful improvements in pat=
ient-reported and investigator-assessed outcomes for both 7 mg/kg and 10 mg=
/kg doses. Both doses were generally well tolerated. If approved in the fut=
ure, rozanolixizumab represents a potential additional treatment option for=
adult patients with generalized myasthenia gravis.=E2=80=9D
In the RAISE study^2 (n=3D174), in adult patients with mild to severe AChR-=
Ab+ gMG, zilucoplan demonstrated rapid efficacy, with consistent, sustained=
, clinically meaningful and statistically significant improvements versus p=
lacebo from baseline to week 12 in both patient and clinician-reported endp=
oints, including MG-ADL, which was the primary efficacy endpoint, and QMG, =
MGC and MGQoL15, which were secondary efficacy endpoints (the threshold for=
clinically meaningful MG-QoL15r has not yet been established).^2 At Week 1=
2, more patients receiving zilucoplan, achieved a =E2=89=A53-point reductio=
n in MG-ADL score without rescue therapy, compared with those receiving pla=
cebo (73% and 46%, respectively; odds ratio [95% CI] =3D 3=C2=B718 [1=C2=B7=
66, 6=C2=B710]; p=3D0=C2=B70005;). Additionally, more patients receiving zi=
lucoplan, compared with those receiving placebo, (58% and 33%, respectively=
) achieved a =E2=89=A55-point reduction in QMG score without rescue therapy=
at Week 12 (odds ratio [95% CI] =3D 2=C2=B787 [1=C2=B752, 5=C2=B740]; p=3D=
0=C2=B70012;).
Zilucoplan was generally well tolerated with a favorable safety profile. Th=
e most frequently reported TEAEs in the zilucoplan group were injection sit=
e bruising, headache, diarrhea, and (worsening of) MG.^2 Incidences of seri=
ous TEAEs and serious infections were similar in both groups. All patients =
who completed the 12-week treatment period (n=3D166) chose to enroll in RAI=
SE-XT, the ongoing open label extension study.^2 If approved, zilucoplan wo=
uld be the first C5 complement inhibitor in gMG that patients can self-admi=
nister at home.
=E2=80=9CIn the RAISE study, zilucoplan showed rapid and clinically meaning=
ful improvements in myasthenia gravis-specific efficacy outcomes, had a fav=
orable safety profile, and was generally well tolerated, with no major safe=
ty findings,=E2=80=9D said James F. Howard, MD, Distinguished Professor of =
Neuromuscular Disease, Professor of Neurology, Medicine and Allied Health, =
The University of North Carolina at Chapel Hill School of Medicine and lead=
investigator in the RAISE trial. =E2=80=9CThese results suggest that, if a=
pproved in the future, zilucoplan could present a potential new treatment o=
ption for a broad population of adult patients with AChR-Ab+ generalized my=
asthenia gravis.=E2=80=9D
Earlier this year, the US Food and Drug Administration (FDA) accepted UCB=
=E2=80=99s filing to review a Biologic License Application (BLA) for rozano=
lixizumab for the treatment of gMG in adult patients. The BLA was designate=
d for Priority Review, with a response from the agency anticipated in Q2 20=
23. This BLA followed the European Medicines Agency=E2=80=99s (EMA) validat=
ion of the Marketing Authorization Application (MAA) for rozanolixizumab, a=
nd the FDA=E2=80=99s acceptance of a New Drug Application (NDA) and the EMA=
=E2=80=99s validation of the MAA for zilucoplan in the same indication. Reg=
ulatory applications for rozanolixizumab and zilucoplan for the treatment o=
f gMG have also been filed in Japan. Responses from regulatory agencies to =
these submissions are expected in H2 2023.=C2=A0
=C2=A0
=E2=80=9COur ultimate goal is to provide targeted treatment options that ca=
n help reduce the ongoing daily burden of gMG, giving patients additional f=
lexible treatment options that work alongside their daily life,=E2=80=9D sa=
id Charl van Zyl, Executive Vice President Neurology Solutions & Head of EU=
/International Markets, UCB. =E2=80=9CWith measures such as MGS-PRO in the =
MycarinG study, we have been able to see the positive impact rozanolixizuma=
b has had on patient experience, while results from the RAISE study demonst=
rated the potential of zilucoplan as an effective and generally well-tolera=
ted treatment that can be self-administered at home, giving people greater =
independence. These results bring us one step forward towards offering tail=
ored options to meet individual patient needs.=E2=80=9D =C2=A0
gMG is a rare, chronic, heterogeneous (phenotypic and pathogenic), and unpr=
edictable auto-immune disease characterized by dysfunction and damage at th=
e neuromuscular junction.^3 Several factors are understood to be drivers of=
gMG disease pathology, including complement, immune cells and pathogenic I=
gG autoantibodies.^4
People living with gMG can experience a variety of symptoms, including droo=
ping eyelids, double vision, and difficulty in swallowing, chewing and talk=
ing, as well as severe muscle weakness that can result in life-threatening =
weakness of the muscles of respiration.^5,6 MG is a rare disease with a glo=
bal prevalence of 100=E2=80=93350 cases per every 1 million people.^7
For further information, contact UCB:=C2=A0
Brand Communications, Rare Diseases
Jim Baxter
T+32.2.473.78.85.01=C2=A0
jim.baxter@ucb.com=C2=A0
Corporate Communications, Media Relations
Laurent Schots=C2=A0
T+32.2.559.92.64 =C2=A0
Laurent.schots@ucb.com=C2=A0
Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0=C2=A0
T +32.2.559.94.14=C2=A0
antje.witte@ucb.com
About the rozanolixizumab MycarinG study^8
The MycarinG study (NCT03971422) is a multi-center, Phase 3, randomized, do=
uble-blind, placebo-controlled study evaluating the efficacy and safety of =
rozanolixizumab in adult patients with gMG, with an open-label extension.^1=
The primary endpoint for the MycarinG study is change from baseline to day=
43 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score, an =
eight-item patient-reported scale developed to assess MG symptoms and their=
effects on daily activities.^1 Additional secondary endpoints include resp=
onse rates, changes in the Myasthenia Gravis Composite (MGC) score, the Qua=
ntitative MG (QMG) score, patient-reported outcomes and treatment-emergent =
adverse events (TEAEs) from baseline to day 43.^1 The majority of patients =
taking part in the MycarinG study opted to enroll in the open-label extensi=
ons to this clinical trial. As a result, UCB is exploring the potential for=
further extension studies into this treatment.^9
For more information about the trial, visit https://clinicaltrials.gov/ct2/=
show/NCT03971422.
About rozanolixizumab
Rozanolixizumab is a SC administered, humanized monoclonal antibody that sp=
ecifically binds, with high affinity, to human neonatal Fc receptor (FcRn).=
It has been designed to block the interaction of FcRn and Immunoglobulin G=
(IgG), accelerating the catabolism of antibodies and reducing the concentr=
ation of pathogenic IgG autoantibodies.^10,11
Rozanolixizumab is under clinical development with the aim of improving the=
lives of people with pathogenic IgG-autoantibody-driven autoimmune disease=
. In 2019, the US FDA granted orphan drug designation to rozanolixizumab fo=
r the treatment of myasthenia gravis.^12 Orphan designation was granted in =
2020 by the European Commission to rozanolixizumab for the treatment of mya=
sthenia gravis.^13
The safety and efficacy of rozanolixizumab have not been established and it=
is not approved for use in any indication by any regulatory authority worl=
dwide.
About the zilucoplan RAISE study^14
The RAISE study (NCT04115293) was a multi-center, Phase 3, randomized, doub=
le-blind, placebo-controlled study to confirm the efficacy, safety, and tol=
erability of zilucoplan in adult patients with AChR-Ab+ gMG. Patients were =
randomized in a 1:1 ratio to receive daily subcutaneous (SC) doses of 0.3 m=
g/kg zilucoplan or placebo for 12 weeks.
The primary endpoint for the RAISE study was change from baseline to Week 1=
2 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score. Secon=
dary endpoints included change from baseline in the Quantitative Myasthenia=
Gravis (QMG) score, the Myasthenia Gravis Composite (MGC) and the Myasthen=
ia Gravis Quality of Life 15 revised (MG-QoL15r)f score from baseline to We=
ek 12, time to first rescue therapy, the proportion of patients with minima=
l symptom expression (MSE) (defined as MG-ADL of 0 or 1 without rescue ther=
apy), the proportion with a =E2=89=A53-point reduction in MG-ADL and the pr=
oportion with a =E2=89=A55-point reduction in QMG, all measured at Week 12.=
Secondary safety endpoint was incidence of TEAEs. Patients who completed t=
he RAISE trial had the possibility to enter the open-label extension study,=
RAISE-XT (NCT04225871).^2=C2=A0
For more information about the trial visit https://clinicaltrials.gov/ct2/s=
how/NCT04115293
About zilucoplan
Zilucoplan is a once-daily SC, self-administered peptide inhibitor of compl=
ement component 5 (C5 inhibitor) under clinical development by UCB in gMG. =
As a C5 inhibitor, zilucoplan inhibits complement-mediated damage to the ne=
uromuscular junction through its targeted dual mechanism of action.^2 In 20=
19, the US FDA granted orphan drug designation to zilucoplan for the treatm=
ent of myasthenia gravis.^15 Orphan designation was granted in 2022 by the =
European Commission to zilucoplan for the treatment of myasthenia gravis.^1=
6
The safety and efficacy of zilucoplan have not been established and it is n=
ot currently approved for use in any indication by any regulatory authority=
worldwide.
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 the central nervous system. With approximately 8 700 people i=
n approximately 40 countries, the company generated revenue of =E2=82=AC 5.=
5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB).=C2=A0
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=
=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=
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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=
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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 partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces 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 p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=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 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 =
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=
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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=
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References:
1. Bril V. Efficacy and safety of rozanolixizumab in patients with generali=
sed myasthenia gravis: a randomised, double-blind, placebo-controlled, adap=
tive Phase 3 study MyCarinG study. The Lancet Neurology. 2023. Published on=
line. Available at: http://www.thelancet.com/journals/laneur/article/PIIS14=
74-4422(23)00077-7/fulltext=C2=A0
=C2=A0
2. Howard J, Efficacy and safety of zilucoplan in patients with generalised=
myasthenia gravis: A randomised, double-blind, placebo-controlled, Phase 3=
study (RAISE). The Lancet Neurology. 2023. Published online. Available at:=
http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(23)00080-7/=
fulltext (https://protect-us.mimecast.com/s/-bYZCW61PrfVJJ6MTO5wVc?domain=
=3Deur02.safelinks.protection.outlook.com)
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3.
5. Myasthenia Gravis Foundation of America. Clinical Overview of MG. https:=
//myasthenia.org/Professionals/Clinical-Overview-of-MG. Accessed February 2=
023
6. Hansen JS, et al. Mortality in myasthenia gravis: A nationwide populatio=
n-based follow-up study in Denmark. Muscle Nerve. 2016; 53: 73-77.
7. Punga, Anna Rostedt et al. =E2=80=9CEpidemiology, diagnostics, and bioma=
rkers of autoimmune neuromuscular junction disorders.=E2=80=9D The Lancet. =
Neurology vol. 21,2 (2022): 176-188. doi:10.1016/S1474-4422(21)00297-0
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olixizumab in Adult Patients With Generalized Myasthenia Gravis=E2=80=99: =
=C2=A0https://clinicaltrials.gov/ct2/show/NCT03971422. Accessed February 20=
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9. ClinicalTrials.gov =E2=80=98A Study to Evaluate Rozanolixizumab in Study=
Participants With Generalized Myasthenia Gravis=E2=80=99. https://clinical=
trials.gov/ct2/show/NCT04650854?term=3DRozanolixizumab&draw=3D2&rank=3D3
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rum IgG concentration: A randomized Phase 1 study. Sci Transl Med. 2017;9(4=
14:eaan1208).
11. Smith B, et al. Generation and characterization of a high affinity anti=
-human FcRn antibody, rozanolixizumab, and the effects of different molecul=
ar formats on the reduction of plasma IgG concentration. MAbs. 2018;10:1111=
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12. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts=
/opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D669918. Accessed March 2023
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/orphan-designations/eu3202272. Accessed March 2023
14. ClinicalTrials.gov =E2=80=98Safety, Tolerability, and Efficacy of Ziluc=
oplan in Subjects With Generalized Myasthenia Gravis (RAISE)=E2=80=99: http=
s://clinicaltrials.gov/ct2/show/NCT04115293. Accessed March 2023.
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/opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D699319. Accessed March 2023.
16. Data on file, UCB inc
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