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ATH434 dose level 1

Phase 2

Multiple System Atrophy | Small molecule | Other |Alterity Therapeutics Limited|Last Updated: Dec 13, 2024

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05109091Study of ATH434 in Participants with Multiple System AtrophyPHASE2 COMPLETED 77 — — Jul 1, 2022Nov 28, 2024Dec 13, 202423 United States, Australia +4
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Study Endpoints
Primary Endpoints
Change in iron content as measured by brain MRI
Change from Baseline to Week 52
Secondary Endpoints
Change in Neurofilament Light Chain Levels
Change from Baseline to Week 52
Change in Unified MSA Rating Scale (UMSARS) Score
Change from Baseline to Week 52
Change in SF-36 Score
Change from Baseline to Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATH434 Arm 1EXPERIMENTAL -
ATH434 Arm 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ATH434 dose level 1DRUGATH434 taken BID
ATH434 dose level 2DRUGATH434 taken BID
PlaceboDRUGPlacebo taken BID
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites23

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 is ambulatory. 5. Participant has biomarker evide...

Countries:United StatesAustraliaFranceItalyNew ZealandUnited Kingdom
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