Clinical TrialMay 11, 2026, 07:28 AM
Alterity Study Validates QSM as MSA Biomarker; Supports ATH434
AI Summary
Alterity Therapeutics announced the publication of a peer-reviewed study in NeuroImage, validating quantitative susceptibility mapping (QSM) MRI as a biomarker for Multiple System Atrophy (MSA). The study, utilizing data from Alterity's bioMUSE study, demonstrated QSM's ability to detect disease-specific iron accumulation, distinguish MSA from Parkinson's disease, and correlate with clinical severity. These findings support QSM as an objective imaging biomarker for earlier diagnosis and assessing iron-modulating therapies like Alterity's lead candidate, ATH434, which is progressing towards a Phase 3 trial for MSA following positive FDA feedback.
Key Highlights
- Peer-reviewed study in NeuroImage validated QSM MRI as a biomarker for Multiple System Atrophy (MSA).
- QSM detected significantly higher iron content in MSA patients' lentiform nucleus (p<0.05) vs. controls and Parkinson's disease.
- Iron content in globus pallidus distinguished MSA from Parkinson's disease with AUC = 0.76–0.79.
- Higher iron content correlated with greater overall disease severity on the UMSARS scale.
- Preliminary 12-month analysis showed progressive increase in abnormal iron accumulation in early-stage MSA.
- Findings support QSM as an objective imaging biomarker for ATH434, Alterity's lead candidate.
- Alterity is advancing ATH434 to a Phase 3 program for MSA, with positive FDA feedback.
- End-of-Phase 2 meeting with FDA for ATH434 is on track for mid-2026.