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CNP520

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Novartis AG|Last Updated: Aug 11, 2017

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 Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02576639Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of AgePHASE2 COMPLETED 124Aug 10, 2015Mar 11, 2016Aug 11, 201711 United States, Belgium +3
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Study Endpoints
Primary Endpoints
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
13 weeks

Safety monitoring was conducted throughout the study.

Secondary Endpoints
Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations
Day 92
Summary of Plasma PK Parameter: Cmax
Days 1, 91
Summary of Plasma PK Parameter: AUCtau
Days 1 and 91
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORMatching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
CNP520 2 mgEXPERIMENTALCNP520 2 mg was taken qd orally for 13 weeks.
CNP520 10 mgEXPERIMENTALCNP520 10 mg was taken qd orally for 13 weeks.
CNP520 35 mgEXPERIMENTALCNP520 35 mg was taken qd orally for 13 weeks.
CNP520 85 mgEXPERIMENTALCNP520 85 mg was taken qd orally for 13 weeks.
Interventions
NameTypeDescription
CNP520DRUG -
PlaceboDRUGMatching placebo to CNP520 was supplied in capsules.
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Eligibility Criteria
Age Range60 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites11

Key Inclusion Criteria: * Healthy status * Body weight: ≥45kg * BMI: 18-34 kg/m2 Key Exclusion Criteria: * History or presence of any clinically significant disease of any major system organ class. * Heavy smoker status * History /presence of clinically significant neurological or psychiatric dis...

Countries:United StatesBelgiumGermanyNetherlandsUnited Kingdom
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