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PRX002

Phase 1

Parkinson's Disease | Monoclonal antibody | Neurology |Prothena Corporation plc|Trials Updated: Oct 21, 2016

PRX002 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Mar 2014

PRX002 target and mechanism

Molecular targetalpha-synuclein
Target classProtein
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment104

FDA Designations

No designations recorded

PRX002 clinical trials

PRX002 · 2 trials · 1 indication

Phase 1 2
NCT02157714Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseaseParkinson's Disease
COMPLETED64 Analytics
NCT02095171Single Ascending Dose Study of PRX002 in Healthy SubjectsParkinson's Disease
COMPLETED40 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of PRX002 in Healthy Subjects
Parkinson's DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about PRX002

What is PRX002 used for in Parkinson's Disease?

PRX002 is an investigational monoclonal antibody being developed for the treatment of Parkinson's disease. It has been studied in Phase 1 clinical trials in both healthy volunteers and patients with Parkinson's disease. It is not approved for any indication and remains in clinical development.

What does PRX002 target?

PRX002 targets alpha-synuclein, a protein that aggregates in the brains of people with Parkinson's disease. By binding to alpha-synuclein, the antibody is designed to interfere with the spread of the pathological form of the protein. Alpha-synuclein is the molecular target of PRX002.

Who is developing PRX002?

PRX002 is being developed by Prothena Corporation plc, which trades on the Nasdaq under the ticker PRTA. Prothena is a clinical-stage neuroscience company focused on protein dysregulation diseases, and PRX002 is its monoclonal antibody candidate for Parkinson's disease.

What phase is PRX002 in?

PRX002 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one single ascending dose study in healthy subjects and one multiple ascending dose study in patients with Parkinson's disease. The program has not advanced beyond Phase 1 based on the trials conducted to date.

What clinical trials is PRX002 in?

PRX002 has been evaluated in two completed Phase 1 trials. NCT02095171 was a single ascending dose study in healthy subjects that enrolled 40 participants. NCT02157714 was a multiple ascending dose study in patients with Parkinson's disease that enrolled 64 participants. Both trials were conducted in the United States.

How was PRX002 studied in its clinical trials?

Both PRX002 trials were randomized, double-blind, and placebo-controlled Phase 1 studies. Together they enrolled 104 participants across healthy volunteers and patients with Parkinson's disease. The single ascending dose trial enrolled adults aged 21 and older, while the multiple ascending dose trial enrolled patients aged 40 and older.