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CERE-110: Adeno-Associated Virus Delivery of NGF

Phase 1

Alzheimer's Disease | Gene therapy | Neurology |Sangamo Therapeutics, Inc.|Last Updated: Nov 10, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00087789CERE-110 in Subjects With Mild to Moderate Alzheimer's DiseasePHASE1 COMPLETED 10 — — Jun 1, 2004May 1, 2010Nov 10, 20222 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of three different doses of CERE-110 in subjects with mild to moderate Alzheimer's disease
24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
CERE-110: Adeno-Associated Virus Delivery of NGFGENETICCERE-110 2.0 x 10\^10 vg, CERE-110 1.0 x 10\^11 vg, CERE-110 2.0 x 10\^11 vg
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Eligibility Criteria
Age Range50 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Alzheimer's disease as determined by NINCDS/ADRDA criteria. * Score of ≤ 4 on a modified Hachinski Ischemia Scale * Mini-Mental State Exam (MMSE) score in the range of 16 to 28, inclusive * No significant neurological or medical abnormalities contraindicating surgery, MRI/PET ...

Countries:United States
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Competitive Landscape -Alzheimer's Disease 68 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline/Trospium Chloride, Xanomeline Enteric, BMS-986446
Eli Lilly and CompanyLLY13PHASE3Donanemab, Dexamethasone, Remternetug, Mevidalen, LY3954068
Biogen Inc.BIIB2PHASE3Lecanemab
Annovis Bio IncANVS1PHASE3buntanetap/posiphen
ACADIA Pharmaceuticals Inc.ACAD2PHASE3ACP-204
Novartis AG Sponsored ADRNVS2PHASE2VHB937, NIO752
Merck & Co., Inc.MRK2PHASE2MK-1167, MK-2214
GSK plc Sponsored ADRGSK2PHASE2GSK4527226
Cognition Therapeutics, Inc.CGTX2PHASE2CT1812
Johnson & JohnsonJNJ1PHASE2JNJ-64042056
Acumen Pharmaceuticals, Inc.ABOS1PHASE2sabirnetug
Lantheus Holdings IncLNTH2PHASE3Nilotinib BE, PI-2620
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
IGC Pharma, LLCIGC1PHASE2IGC-AD1-Active
Alnylam Pharmaceuticals, IncALNY2PHASE1ALN-5288, ALN-APP
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-MAPT-
Denali Therapeutics Inc.DNLI1PHASE1DNL628
AC Immune SAACIU2PHASE1ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b, ACI-24.060 at Dose A in Study Part 2
Alzamend Neuro, Inc.ALZN1PHASE1ALZN002 .
Voyager Therapeutics, Inc.VYGR1PHASE1VY7523
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