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PRX002

Phase 1

Parkinson's Disease | Small molecule | Neurology |Prothena Corporation plc|Last Updated: Oct 21, 2016

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 Trials2
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02157714Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseasePHASE1 COMPLETED 64Jun 1, 2014 -Oct 21, 20168 United States
NCT02095171Single Ascending Dose Study of PRX002 in Healthy SubjectsPHASE1 COMPLETED 40Mar 1, 2014 -Feb 10, 20151 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability as determined by number of subjects with adverse events
up to 6 months
Determination of pharmacokinetics parameters
up to 6 months

maximum concentration (Cmax)

Secondary Endpoints
Immunogenicity as determined by measurement of anti-PRX002 antibodies
up to 3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRX002EXPERIMENTALPRX002
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
PRX002DRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Idiopathic Parkinson's disease, Hoehn and Yahr 1-3 * Body weight range of ≥ 45kg/99 lbs to ≤ 110 kg/242 lbs * Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception * Male subjects and their partners of childbearin...

Countries:United States
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