- Alterity Therapeutics (ATHE, Financial) demonstrates promising results in Phase 2 trial of ATH434 for Multiple System Atrophy (MSA).
- 50mg dose resulted in a 48% reduction in clinical progression, showing higher efficacy than the 75mg dose.
- Wearable sensors confirmed increased patient activity and mobility, supporting ATH434's potential as a therapeutic option.
Alterity Therapeutics (ATHE) has unveiled new data from its ATH434 Phase 2 trial for Multiple System Atrophy (MSA) at the 2025 Annual Meeting of the American Academy of Neurology. The double-blind study reported significant efficacy, with the 50mg dose showing a 48% decrease in clinical progression (p=0.02) on the modified UMSARS I scale, outperforming the 75mg dose which recorded a 30% decrease.
Key findings included a nominally significant improvement in the Clinical Global Impression of Severity Scale at the 50mg dose (p=0.0088) and positive outcomes from Orthostatic Hypotension Symptom Assessment. Crucially, wearable sensors revealed increased activity levels, with improvements observed in step count, walking time, and standing time.
Imaging outcomes from 61 participants showed that ATH434 effectively reduces the iron signal in MSA-affected brain regions, indicative of successful target engagement. The therapy's mechanism was further supported by data from the bioMUSE study, which validated the use of wearable sensors in capturing meaningful clinical data.
David Stamler, CEO of Alterity, stated, "The clinical results from this study are important given the lack of available treatments to address the underlying pathology in MSA." The company plans to engage with regulatory bodies, including the U.S. FDA, to further advance ATH434 as a potentially disease-modifying treatment for MSA.
The new findings suggest ATH434 could significantly impact MSA treatment development, offering hope for a condition with no currently approved disease-modifying therapies. Alterity's successful Phase 2 results position it favorably for future development steps, despite the need for additional Phase 3 studies.
