medimmune nmo clinical trial webinar 9:00 a.m. pst, 12 p.m
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N-MOmentumA Clinical Research Study for Neuromyelitis Optica
MedImmune NMO Clinical Trial Webinar
9:00 a.m. PST, 12 p.m. EST
Wednesday, 12/17/14
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Webinar Format
Session is 45 minutes in length (Welcome, Intro, Presentation, Q&A)
Attendees may submit questions in the Q&A window online - please be as succinct as possible if you choose to submit a question
After the presentation is complete, the presenters & panelists will address as many questions as time allows
Thank you for understanding that not all questions will be addressed
Webinar slides and audio will be posted on the foundation website for later viewing / audio
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Presenter
Armando Flor, M.D.Director of Clinical DevelopmentMedImmune
Michael Yeaman, Ph.D.Advisor, The Guthy-Jackson
Charitable Foundation
Brian Weinshenker, M.D.Expert NMO ClinicianMayo Clinic
Panelist Moderator3
Presentation Format Content is solely that of the respective industry or its representative
Presenters are afforded a maximum of 15-20 minutes total time
Questions / answers are then afforded up to 20 minutes of time
The webinar is being recorded for purposes of future distribution
All perspectives are offered only for stakeholder self-education
The Guthy-Jackson Charitable Foundation does not perform clinical trials nor does it endorse any particular clinical trial design or drug
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• B-cells have important roles in the pathogenesis of autoimmune diseases including
NMO
• CD-19 B cells are responsible for the production of the AQP4 autoantibodies
MEDI-551
Evidence suggests
CD-19 B lymphocyte
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MEDI-551
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• Humanized, monoclonal antibody that binds with high
affinity to CD19 B cells
• Depletes B cells using body’s own immune system
What is MEDI-551?
• Phase I in Scleroderma completed
• Phase I in Multiple Sclerosis completed
• Phase II/III in NMO/NMOSD initiated
• Phase II in B cell malignancies on-going
Phase of development of MEDI-551
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Pre-B
Receptor
Cytoplasmic
chain
IgM IgM/IgD IgG
Class Switch
CD19
CD20
CD22
CD19
CD20
CD22
Bone Marrow Periphery
Plas
ma blas
ts
Early
pro
-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B c
ell
Plasm
a ce
ll
Stem
cel
l
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early pro-B
Late pro-B
Large pre-B
Sm
all pre-B
Imm
ature B
Naive B
cell
Mature B
cell
Plasma cell
Stem cell
Plas
ma Cells
Pro-
B cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Early p
ro-B
Late
pro
-B
Larg
e pr
e-B
Sm
all p
re-B
Imm
atur
e B
Nai
ve B
cel
l
Mat
ure
B cel
l
Plasm
a ce
ll
Stem
cell
Stem
Cell
Larg
e Pr
e-B cell
Small P
re-B
cell
Immatur
e B
cell
Naïve
B cell
Mat
ure B
cell
Mem
ory B
cell
Rituximab
MEDI-551: Targets a Broader Spectrum of B Cells
MEDI 551
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• Population: Sero-positive and sero-negative NMO/NMOSD
subjects.
• Primary endpoint: Time to first attack
• Drug: MEDI-551 300 mg Intravenously at Day 1 and Day 15
and then every 6 months
• Comparator: Placebo
• Randomization ratio: 3:1 (MEDI-551: Placebo) 75% on MEDI551 25% on
placebo
• Treatment period: 6.5 months (197 days) followed by open label period
• Study end: 67 adjudicated attacks
• Safety monitoring: Telephone calls every two weeks. Liberal escape
allows treating physician to treat attacks with
rescue medications
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Placebo Study Design
1212
Screening
28 days
Randomization
3:1
MEDI-511 (3)
Placebo (1)
Open Label
Period (min 1y max 3 y)
(MEDI-551 only)
Primary EndpointTime to NMO Attack
During Randomized
Controlled Period
Total of 67 relapses required
Randomized Controlled Period – 6.5 months
A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
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A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
Eligibility
(please visit https://clinicaltrials.gov/ct2/show/NCT02200770?term=NMO&rank=8 for the complete list
of the inclusion/exclusion criteria)
Key Inclusion Criteria
Men and women 18 years or older with diagnosis of NMO/NMOSD
Seropositive or seronegative NMO/NMOSD patients with at least one attack in one
year or two attacks in the last two years requiring rescue therapy prior randomization
Expanded Disability Status EDSS ≤ 7.5
Key Exclusion Criteria:
Lactating and pregnant females
Know history of a severe allergic reaction or anaphylaxis after any biologic therapy
Known active severe bacterial, fungal or viral infection or any major episode of
infection requiring hospitalization.
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A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
Eligibility
Exclusion Criteria: (cont’)
NMO patients diagnosed with a concurrent autoimmune disease requiring
immunosuppressive agents.
History of cancer, apart form squamous cell or basal cell carcinoma of the skin with
documented success of curative therapy.
Receipt of Rituximab, unless the subject’s B cells have returned to the normal limit
of normal prior randomization.
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A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
Concomitant Medications:
Prednisone
Two weeks of 20 mg/day of prednisone follow by one week of tapering during
randomized period.
MEDI-551 is not biologically active for first 2 weeks
Supports tapering for patients previously on steroids
Infusion Reaction prophylaxis:
IV methylprednisolone (Steroids)
Benadryl
Tylenol
Rescue Medications
Immunosuppressant therapy after randomization is not permited
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A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
Study Visit details:
Screening visit:
– AQP4-IgG sero-status
– Physical/neurological examination
– Vitals signs and ECG
– Blood and urine collection
– EDSS and ophthalmology examination
– MRI
9 Randomized controlled period visit at days: 1,8,15,29,57,85,113,155 and197
– Physical/neurological examination
– Vitals signs
– Blood and urine collection
– Assessment of adverse events
– EDSS and ophthalmology examination at visit day 1, day 85 and day197
– MRI at visit day 197
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Open Label
Period
(MEDI-551 only)Randomizatio
n
3:1
Screening
28 days
MEDI-511 (3)
Placebo (1)
Randomized Controlled Period – 6.5 months
Safety Follow-up
Period
Beyond the randomized controlled period
Open Label period:
Gather extended safety data
Opportunity for patient to receive a B cell depleting agent
Minimum for 1 year, maximum for 3 years, or until local approval
Safety Follow-up period:
All about B cell recovery
Follow-up for 12 months after last dose of MEDI-551
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A Double-masked, Placebo-controlled Study with
Open-label Period in Adult Subjects with
NMO/NMOSD
SUMMARY
– MEDI-551 depletes CD 19 B cells source of production of AQP4-IgG
autoantibodies that cause NMO
– N-Momentum is a pure placebo controlled study with a masked treatment
period of 6.5 months and a randomization of 3:1, where 75% of patients
will be on MEDI-551 and 25% will be on placebo only.
– After the randomized controlled period, trial participants will have the
option to enter the Open Label period where all participants will received
MEDI 551
– For more information, please visit
https://clinicaltrials.gov/ct2/show/NCT02200770?term=NMO&rank=8 or
contact the AstraZeneca Clinical Study Information Center at
1-877-240-9479 or email information.center@astrazeneca.com
Learn More
This webinar will be hosted on the
foundation website at:
http://nmotion.guthyjacksonfoundation.org/series-one-nmo-
clinical-trial-update/
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Conclusion
Content is solely that of the respective industry or its representative
Webinar slides and audio will be posted on the foundation website for later viewing/audio
All perspectives are offered only for stakeholder self-education
The Guthy-Jackson Charitable Foundation does not perform clinical trials nor does it endorse any particular clinical trial design or drug
We hope this webinar has been informative to all stakeholders
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