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BIIB076

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Biogen Inc.|Last Updated: Mar 24, 2020

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03056729Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's DiseasePHASE1 COMPLETED 46 — — Feb 17, 2017Mar 3, 2020Mar 24, 20208 United States
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Study Endpoints
Primary Endpoints
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Week 20

Safety surveillance

Secondary Endpoints
BIIB076 serum pharmacokinetics (PK) concentration levels
Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)
Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Up to Week 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort HV1EXPERIMENTAL -
Cohort HV2EXPERIMENTAL -
Cohort HV3EXPERIMENTAL -
Cohort HV4EXPERIMENTAL -
Cohort HV5EXPERIMENTAL -
Cohort AD1EXPERIMENTAL -
Interventions
NameTypeDescription
BIIB076DRUGAdministered as single intravenous (IV) infusion
PlaceboDRUGAdministered as single IV infusion
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Eligibility Criteria
Age Range50 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites8

Key Inclusion Criteria - Healthy Participants * Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Key Inclusion Criteria - Participants with Alzheimer's Disease (AD) * Must meet all of the clinical criteria for mild cognitive impairment ...

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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