UCB (EBR:UCB) UCB Media Room: UCB presents latest data from generalized myasthenia gravis portfolio at AANEM meeting
Directive transparence : information réglementée
22/09/2022 07:00
https://mb.cision.com/Public/18595/3634655/97a5454c47e4c409_800x800ar.png
** UCB presents latest data from generalized myasthenia gravis portfolio at=
AANEM meeting
------------------------------------------------------------
=C2=B7 Results presented across UCB=E2=80=99s generalized myasthenia gravis=
(gMG) development program builds the body of evidence around the complexit=
ies of gMG=C2=A0
=C2=B7 Presentations to include data from the Phase 3 MycarinG study of roz=
anolixizumab as well as the Phase 3 RAISE and RAISE-XT studies of zilucopla=
n
Brussels (Belgium), 22 September 2022 =E2=80=93 7:00 (CEST) =E2=80=93 UCB, =
a global biopharmaceutical company, announced today it is presenting result=
s from across its portfolio in generalized myasthenia gravis (gMG) at the A=
merican Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) a=
nnual meeting featuring the Myasthenia Gravis Foundation of America (MGFA) =
Scientific Session, September 21 =E2=80=93 24. Presentations include study =
results for its investigational treatments, zilucoplan, a self-administered=
, subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibit=
or) and rozanolixizumab, an SC-infused monoclonal antibody targeting the ne=
onatal Fc receptor (FcRn), in adults with gMG. In addition, the company is =
also presenting real-world findings into the burden of the disease for soci=
ety and the potential role of a digital application in improving care.=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=9CPatients living with gMG experience high disease and treatment bur=
den resulting in a significant impact on their daily lives. The data being =
presented at AANEM and the MG Scientific Session reinforce the potential of=
UCB=E2=80=99s two investigational medicines with different mechanisms of a=
ction to provide targeted treatment options to patients,=E2=80=9D said Iris=
Loew-Friedrich, Executive Vice President and Chief Medical Officer at UCB.=
=E2=80=9CWe are committed to meeting patients=E2=80=99 needs, regardless o=
f antibody profile, including those with MuSK Ab+ gMG who have particularly=
limited treatment options. With our gMG pipeline, we hope to address both =
drivers of disease pathology and which account for approximately 95% of pat=
ients living with gMG.=E2=80=9D
Rozanolixizumab MycarinG Phase 3 Results
A subgroup analysis presented from the Phase 3 MycarinG study (Poster 16, M=
GFA Scientific Session)^1=C2=A0 =C2=A0analyzes the efficacy of rozanolixizu=
mab in patients with muscle specific kinase antibody-positive (MuSK-Ab+) gM=
G, which is often more severe and harder to treat than acetylcholine recept=
or antibody positive (AChR-Ab+) gMG.^2 In the analysis, rozanolixizumab dem=
onstrated statistically significant and clinically meaningful improvements =
in MG-specific outcomes in patients with MuSK-Ab+ gMG, that were consistent=
with results in AChR-Ab+ gMG and the overall population. Improvements in M=
yasthenia Gravis-Activities of Daily Living (MG-ADL) score for the overall =
population (n=3D200), including MuSK-Ab+ patients, were -3.37 for 7mg/kg (n=
=3D66; 5 MuSK Ab+) and -3.40 for 10mg/kg (n=3D67) vs -0.78 (n=3D67) for pla=
cebo. In the MuSK-Ab+ specific 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+ specific 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).^1
In a responder analysis from MycarinG (Poster 204, AANEM)^3, results presen=
ted demonstrated that rozanolixizumab significantly reduced MG-ADL from bas=
eline to Day 43. In this primary endpoint, rozanolixizumab showed an LS mea=
n difference vs placebo of 2.59 points at the 7mg/kg dose and 2.62 points a=
t the 10mg/kg dose. Furthermore, a greater percentage of patients in the ro=
zanolixizumab 7mg/kg and 10mg/kg arms than the placebo arm achieved a 2.0-p=
oint or greater improvement in MG-ADL, a 3.0-point or greater improvement i=
n Quantitative Myasthenia Gravis (QMG) scores and a 3.0-point or greater im=
provement in Myasthenia Gravis Composite (MGC) scores. Rozanolixizumab had =
an acceptable safety profile and was generally well tolerated with similar =
occurrences of TEAEs between both doses.^3
A further safety analysis of the MycarinG trial (Oral presentation, =E2=80=
=98Clinical Trials 2=E2=80=99 session, MGFA Scientific Session),^4 showed t=
hat rozanolixizumab was generally well tolerated, with the majority of trea=
tment emergent adverse events (TEAEs) being mild to moderate in severity. A=
higher proportion of TEAEs occurred in the active treatment arms versus pl=
acebo (81.3% for 7 mg/kg, 82.6% for 10 mg/kg and 67.2% for placebo) and wer=
e comparable between the rozanolixizumab groups. The most frequently report=
ed TEAEs were headache, diarrhea, pyrexia and nausea. A higher incidence of=
headache was reported in the rozanolixizumab groups versus placebo, with m=
ost cases mild to moderate and severe cases generally managed with non-opio=
id analgesics. There were no severe or serious infections in the rozanolixi=
zumab groups. Treatment withdrawal due to TEAEs was low; the rate was simil=
ar in the rozanolixizumab 7 mg/kg and placebo groups and higher in the roza=
nolixizumab 10 mg/kg group.^4=C2=A0
Zilucoplan Phase 3 RAISE and RAISE-XT Results
An interim analysis from RAISE-XT (data cut off 18 February 2022), a Phase =
3, multicenter, open-label extension study (Poster 14, MGFA Scientific Sess=
ion) is also being presented.^5=C2=A0This ongoing study recruited patients =
with AChR-Ab+ gMG who participated in randomized Phase 2 (NCT03315130) and =
Phase 3 (NCT04115293) zilucoplan studies. Building on the data seen in the =
double-blind Phase 2 and Phase 3 studies, results demonstrated a favorable =
long-term safety profile for zilucoplan over 24 weeks with no major safety =
findings, with efficacy in patients who had previously received zilucoplan =
continuing to improve, and efficacy demonstrated as early as week 1 in pati=
ents who switched from placebo. At extension study Week 12, after 24 weeks,=
the zilucoplan group achieved an LS =C2=A0mean improvement in MG-ADL score=
from the double-blind study baseline of =E2=88=926.30. MG-ADL improvement =
for the placebo-switch group, after 12 weeks of zilucoplan, was =E2=88=926.=
32.=C2=A0
A presentation on the quality-of-life (QoL) outcomes with zilucoplan from t=
he Phase 3 RAISE study (NCT04115293) (Oral presentation, =E2=80=98Clinical =
Trials 2=E2=80=99 session, MGFA Scientific Session)^6 demonstrated that zil=
ucoplan clinically meaningfully and highly statistically significantly impr=
oved MG-ADL at week 12 (LS mean difference v placebo =E2=80=932.09; p<0.001=
) and showed consistently greater improvement in fatigue vs placebo (LS mea=
n difference vs placebo at Week 12, =E2=80=933.06; nominal p=3D0.0069). An =
overall Work Impairment due to problem score with zilucoplan vs placebo (LS=
mean difference vs placebo =E2=80=9312.83; p=3D0.0912) was also observed. =
Zilucoplan demonstrated a favorable safety profile, with a similar rate of =
TEAEs between zilucoplan (76.7%) and placebo (70.5%), and good tolerability=
. The most common TEAEs were injection-site reactions (26.7% zilucoplan vs =
14.8% placebo); all were non-serious, and mild in severity, except for one =
instance of injection-site pain of moderate severity in the zilucoplan grou=
p and no patients discontinued due to an injection-site reaction. All patie=
nts in the zilucoplan arm who completed the 12-week treatment period have e=
ntered the ongoing RAISE-XT extension study (NCT04225871).=C2=A0
Additionally, in a detailed responder analysis from Phase 3 RAISE trial bei=
ng presented (Poster 200, AANEM)^7 significantly higher proportions of pati=
ents receiving zilucoplan achieved =E2=89=A53-point and =E2=89=A55-point im=
provements in MG-ADL and QMG without rescue therapy vs placebo, respectivel=
y Zilucoplan demonstrated a clinically meaningful placebo-corrected mean im=
provement of 2.09 points (p<0.001) in MG-ADL, with 73.1% (p<0.001) of patie=
nts receiving zilucoplan achieving a 3.0-point or greater reduction in MG-A=
DL compared to placebo (46.1%) and 58% (p=3D0.0012) of patients receiving z=
ilucoplan achieving a 5.0-point or greater reduction in QMG compared to pla=
cebo (33.3%). Zilucoplan had a favorable safety profile with no major safet=
y findings and good tolerability.^7
Real-world costs of gMG and digital application supporting patients =C2=A0
Data from a study exploring the health care utilization and societal costs =
of MG in Norway (Poster 9, MGFA Scientific Session)^8 highlighted the burde=
n on both patients and society. It showed that societal costs such as lost =
life years, QoL, and productivity are significant and greater than direct t=
reatment-related costs (estimated to be only 11.5% of societal costs).=C2=
=A0
A further study on the real-world assessment of patient perceptions on an M=
G symptom-tracking application^9 showed the potential of the smartphone app=
lication to equip patients with information that would allow them to better=
communicate their individual disease experience to their healthcare profes=
sional while also making behavioral changes to better manage their disease.=
Further assessment of this application is underway. (Oral presentation, =
=E2=80=98Outcomes=E2=80=99 session, MGFA Scientific Session).=C2=A0
=E2=80=9CWe are proudly and firmly committed to supporting the gMG communit=
y by increasing knowledge and understanding of the true burden of this dise=
ase to help improve outcomes,=E2=80=9D said Charl van Zyl, Executive Vice P=
resident Neurology & Head of Europe/International Markets at UCB. =E2=80=9C=
By focusing on patients and reinforcing our gMG pipeline with a platform of=
support services and digital innovations, we aim to transform the lives of=
people living with this disease.=E2=80=9D=C2=A0
UCB anticipates filing regulatory submissions in the European Union, Japan =
and the U.S. for both zilucoplan and rozanolixizumab later this year.
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 Generalized Myasthenia Gravis (gMG)
Myasthenia gravis is a rare disease impacting almost 200,000 patients in th=
e U.S., EU and Japan.^10,11=C2=A0 People living with gMG can experience a v=
ariety of symptoms, including drooping eyelids, double vision and difficult=
y swallowing, chewing and talking, as well as severe muscular weakness that=
can result in life threatening weakness of the muscles of respiration.^12=
=C2=A0=C2=A0
gMG is a chronic and unpredictable auto-immune disease in which pathogenic =
autoantibodies can inhibit synaptic transmission at the neuro-muscular junc=
tion by targeting specific proteins on the post-synaptic membrane. This dis=
rupts the ability of the nerves to stimulate the muscle and results in a we=
aker contraction.^13 gMG can occur at any age and in any race, although pre=
vious studies have shown that women are more often impacted than men.^12 Mo=
st patients with gMG have pathogenic IgG antibodies that disrupt the transm=
ission of nerve impulses to muscles in the NMJ and some activate the comple=
ment cascade. Complement-mediated destruction via MAC formation is a key me=
chanism causing damage at the NMJ and is the key driver of disease in AChR =
Ab+ gMG.
About the zilucoplan RAISE study^14
The RAISE study (NCT04115293) is a multi-center, Phase 3, randomized, doubl=
e-blind, placebo-controlled study to confirm the efficacy, safety, and tole=
rability of zilucoplan in patients with gMG. Patients were randomized in a =
1:1 ratio to receive daily subcutaneous (SC) doses of 0.3 mg/kg zilucoplan =
or placebo for 12 weeks.
The primary endpoint for the RAISE study is change from baseline to Week 12=
in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score. Second=
ary endpoints include change in the Quantitative Myasthenia Gravis (QMG) sc=
ore, the Myasthenia Gravis Composite (MGC) and the Myasthenia Gravis Qualit=
y of Life 15 revised (MG-QoL15r) score from baseline to Week 12, time to re=
scue therapy, the proportion with minimal symptom expression (MSE) (defined=
as MG-ADL of 0 or 1), the proportion with a =E2=89=A53-point reduction in =
MG-ADL and the proportion with a =E2=89=A55-point reduction in QMG, all mea=
sured at Week 12. Secondary safety endpoint is incidence of TEAEs. Patients=
who completed the RAISE trial had the possibility to enter the open label =
extension study, RAISE-XT (NCT04225871).=C2=A0
For more information about the trial visit https://clinicaltrials.gov/ct2/s=
how/NCT04115293.=C2=A0
About the rozanolixizumab MycarinG study^15=C2=A0
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.=
=C2=A0
The primary endpoint for the MycarinG study is change in the Myasthenia Gra=
vis-Activities of Daily Living (MG-ADL) score, an eight-item patient-report=
ed scale developed to assess MG symptoms and their effects on daily activit=
ies. Additional endpoints include response rates, changes in the Myasthenia=
Gravis composite (MGC) score, the Quantitative MG (QMG) score, patient-rep=
orted outcomes and adverse events (AEs). The majority of patients taking pa=
rt in the MycarinG study opted to enroll in the open label extensions to th=
is clinical trial. As a result, UCB is exploring the potential for further =
extension studies into this treatment.
For more information about the trial, visit https://clinicaltrials.gov/ct2/=
show/NCT03971422.=C2=A0
About Zilucoplan=C2=A0
Zilucoplan is a once-daily self-administered SC peptide inhibitor of comple=
ment component 5 (C5 inhibitor) under clinical development by UCB in gMG. R=
esults from the RAISE study, a multi-center, Phase 3, randomized, double-bl=
ind, placebo-controlled study demonstrated the efficacy, safety, and tolera=
bility of zilucoplan in patients with gMG, and regulatory submissions are p=
lanned in 2022. In 2019, the US FDA granted orphan drug designation to zilu=
coplan for the treatment of myasthenia gravis.^16 Orphan designation was gr=
anted in 2022 by the European Commission to zilucoplan for the treatment of=
myasthenia gravis.^17
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 Rozanolixizumab
Rozanolixizumab is an SC administered, humanized monoclonal antibody that s=
pecifically 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 concent=
ration of pathogenic IgG autoantibodies.^18,19
Rozanolixizumab is under clinical development with the aim of improving the=
lives of people with pathogenic IgG-autoantibody-driven autoimmune disease=
s. In 2019, the US FDA granted orphan drug designation to rozanolixizumab f=
or the treatment of myasthenia gravis.^20 Orphan designation was granted in=
2020^21 by the European Commission for rozanolixizumab for the treatment o=
f myasthenia gravis.
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 UCB in Rare Diseases=C2=A0
At UCB, we don=E2=80=99t just see patients or population sizes, we see peop=
le in need. Through decades of serving the neurology and immunology communi=
ties, we have improved lives with impactful medicines and by enhancing the =
social and emotional well-being of patients. As a continuation of our herit=
age, we are now expanding our efforts to tackle rare neurological and immun=
ological diseases where current options offer little hope, including invest=
igational treatments for gMG, MOG-AD and AIE.
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 7,600 people in=
approximately 40 countries, UCB generated revenue of =E2=82=AC5.3 billion =
in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twi=
tter: @UCB_news
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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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e discovered or identified in the pipeline, will progress to product approv=
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References
1. Habib AA, et al. Efficacy of rozanolixizumab in muscle-specific kinase a=
ntibody-positive generalized myasthenia gravis: Outcomes from the randomize=
d, Phase 3 MycarinG study. Poster 16, MGFA Scientific Session, AANEM 2022.
2. Rodolico C, et al. MuSK-Associated Myasthenia Gravis: Clinical Features =
and Management. Front Neurol. 2020;11:660=C2=A0
=C2=A0
3. Bril V, et al. Rozanolixizumab in generalized myasthenia gravis: Respond=
er analyses from the Phase 3 MycarinG study. Poster 204, AANEM 2022.
4. Vu T, et al. Safety and tolerability of rozanolixizumab in the randomize=
d Phase 3 MycarinG study. Oral presentation, MGFA Scientific Session at AAN=
EM 2022.=C2=A0
5. Genge A, et al. Safety and tolerability of zilucoplan in RAISE-XT: A mul=
ticenter, open-label extension study in patients with generalized myastheni=
a gravis. Poster 14, MGFA Scientific Session, AANEM 2022.=C2=A0
6. Weiss MD, et al, Quality of life outcomes in RAISE: A double-blind rando=
mized, placebo-controlled study of zilucoplan in gMG. Oral presentation. MG=
FA Scientific Session, AANEM 2022.=C2=A0
7. Vu T, et al. Efficacy and safety of zilucoplan in myasthenia gravis: Res=
ponder analysis from the randomized Phase 3 RAISE trial. Poster 200, AANEM =
2022.
8. Bugge C, et al. Burden of myasthenia gravis: Health care utilization and=
societal costs in Norway. Poster 9, MGFA Scientific Session, AANEM 2022.=
=C2=A0
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11. Gilhus N. Myasthenia Gravis. N Engl J Med. 2016;375:2570-2581.
12. Hansen JS, et al. Mortality in myasthenia gravis: A nationwide populati=
on-based follow-up study in Denmark. Muscle Nerve. 2016;53:73-77.
13. Myasthenia Gravis Foundation of America. Clinical Overview of MG. https=
://myasthenia.org/Professionals/Clinical-Overview-of-MG. Accessed August 20=
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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 August 2022.
15. ClinicalTrials.gov =E2=80=98A Study to Test Efficacy and Safety of Roza=
nolixizumab in Adult Patients With Generalized Myasthenia Gravis=E2=80=99: =
=C2=A0https://clinicaltrials.gov/ct2/show/NCT03971422. Accessed August 2022=
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16. US Food and Drug Administration.https://www.accessdata.fda.gov/scripts/=
opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D699319. Accessed August 2022.=
=C2=A0
17. Data on file.
18. Kiessling P, et al. The FcRn inhibitor rozanolixizumab reduces human se=
rum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017;9(4=
14).
19. 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-=
1113.
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/opdlisting/oopd/detailedIndex.cfm?cfgridkey=3D669918. Accessed August 2022
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/orphan-designations/eu3202272. Accessed August 2022=C2=A0
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