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DNL747

Phase 1

Alzheimer Disease | Small molecule | Neurology |Denali Therapeutics Inc.|Last Updated: Feb 26, 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-BlindCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03757325Study to Evaluate DNL747 in Subjects With Alzheimer's DiseasePHASE1 COMPLETED 16Feb 13, 2019Dec 5, 2019Feb 26, 20205 United States, Netherlands
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Study Endpoints
Primary Endpoints
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Randomization - Day 86
Number of Subjects with clinically significant neurological examination abnormalities
Randomization - Day 86
Number of Subjects with laboratory test abnormalities
Randomization - Day 86
Secondary Endpoints
Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL747
Randomization - Day 86
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL747
Randomization - Day 86
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL747
Randomization - Day 86
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
DNL747 First, Placebo SecondEXPERIMENTALSubjects will receive DNL747 for 29 days for the first period and then will switch to placebo for 29 days for the second period. There will be a 14-day washout period between the 2 treatment periods.
Placebo First, DNL747 SecondEXPERIMENTALSubjects will receive placebo for 29 days for the first period and then will switch to DNL747 for 29 days for the second period. There will be a 14-day washout period between the 2 treatment periods.
Interventions
NameTypeDescription
DNL747DRUGDNL747
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range55 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: * Women of non-childbearing potential and men, aged 55-85 years * AD diagnosis based on the 2011 National Institute on Aging-Alzheimer's Association Guidelines * Supportive evidence for diagnosis of AD based upon positive CSF Aβ42 test, or documented history of positive amyl...

Countries:United StatesNetherlands
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