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ATH434

Phase 2

Multiple System Atrophy | Small molecule | Other |Alterity Therapeutics Limited|Last Updated: Apr 1, 2025

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05864365A Biomarker Study of ATH434 in Participants With MSAPHASE2 COMPLETED 10 — — May 23, 2023Feb 26, 2025Apr 1, 20251 United States
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Study Endpoints
Primary Endpoints
Change in brain volume as measured by MRI
Change from Baseline to Week 52
Secondary Endpoints
Change in iron content in substantia nigra as measured by MRI
Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Change from Baseline to Week 52
Change in Patient Global Impression of Change (PGI-C)
Change from Baseline to Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATH434EXPERIMENTAL -
Interventions
NameTypeDescription
ATH434DRUGATH434 taken by mouth two times per day
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Participant has clinical features of parkinsonism. 2. Participant has evidence of orthostatic hypotension and/or bladder dysfunction. 3. Participant has ataxia and/or pyramidal signs on neurological examination. 4. Participant has biomarker evidence of MSA in biologic fluid a...

Countries:United States
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