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DNL151

Phase 1

Parkinson's Disease | Small molecule | Neurology |Biogen Inc.|Last Updated: Apr 18, 2023

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04056689Study to Evaluate DNL151 in Subjects With Parkinson's DiseasePHASE1 COMPLETED 36 — — Jul 23, 2019Dec 2, 2020Apr 18, 20238 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Randomization to Day 42
Number of Subjects with laboratory test abnormalities
Randomization to Day 42
Number of Subjects with vital sign abnormalities
Randomization to Day 42
Number of Subjects with electrocardiogram (ECG) abnormalities
Randomization to Day 42
Number of Subjects with clinically significant neurological examination abnormalities
Randomization to Day 42
Secondary Endpoints
Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151
Randomization to Day 28
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Randomization to Day 28
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Randomization to Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNL151 Low DoseEXPERIMENTAL -
DNL151 Mid DoseEXPERIMENTAL -
DNL151 High DoseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DNL151DRUGOral repeating dose
PlaceboDRUGOral repeating dose
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites8

Key Inclusion Criteria: * Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive * Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H\&Y Stage I, II, or III. * Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments Key E...

Countries:United StatesBelgiumNetherlandsUnited Kingdom
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Competitive Landscape -Parkinson's Disease 59 trials
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