Alterity Therapeutics Presents Positive Data from ATH434 Phase 2 Trial at the 2025 International Congress of Parkinson’s Disease and Movement Disorders

– Data demonstrate ATH434 slows disease progression and stabilizes orthostatic hypotension –

– New analysis increases overall confidence in the Phase 2 trial results –

– State-of-the-art neuroimaging and biomarker analysis advance understanding of MSA diagnosis –

MELBOURNE, Australia and SAN FRANCISCO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced  that data from the ATH434-201 randomized, double-blind Phase 2 clinical trial in Multiple System Atrophy (MSA) was featured at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS) that took place in Honolulu, HI, USA.

“The aggregate data from our double-blind trial continue to demonstrate the potential of ATH434 as a disease modifying therapy for MSA,” said David Stamler, M.D., Chief Executive Officer of Alterity. “The positive data from our ATH434-201 trial have demonstrated a slowing of disease progression and stabilization of orthostatic hypotension, one of the most challenging MSA symptoms to manage. The MDS conference gave us the opportunity to present new analyses from our double-blind Phase 2 trial that increase our overall confidence in ATH434. When we accounted for baseline differences in an important predictor of disease progression, the efficacy signal at the 75 mg dose strengthened meaningfully on the key clinical endpoint of UMSARS I¹ at 52 weeks. This new analysis continues to support our belief that ATH434 has great potential to treat this devastating disease.”

“In addition, we presented data assessing the state-of-the-art neuroimaging and biomarkers employed in our trial to refine the diagnosis of MSA and track the evolution of the disease across the two main clinical phenotypes, MSA-P and MSA-C. We remain committed to advancing ATH434 to the next stage of development while striving to become the market leader dedicated to improving the overall treatment paradigm for MSA,” concluded Dr. Stamler.

Presentation Highlights:

ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy
Presenter: David Stamler, M.D., Chief Executive Officer, Alterity

Dr. Stamler’s oral platform presentation provided results from the ATH434-201 trial with new analyses related to orthostatic hypotension (OH), one of the most debilitating MSA symptoms. Clinical endpoints were analyzed in the clinical analysis population (n=71) that included patients randomized to treatment who had at least one post-baseline assessment of the key clinical endpoint, the UMSARS I. There were three arms in the trial comparing two dose levels of ATH434 50 mg (n=25) and 75 mg (n=24) to placebo (n=22), all of which were administered twice daily. Treatment with ATH434 resulted in a clinically significant reduction in disease severity relative to placebo on the modified UMSARS I activities of daily living scale at both dose levels, with a 48% relative treatment effect at the 50 mg dose (p=0.02)² and a 30% relative treatment effect at the 75 mg dose at 52 weeks. UMSARS I is the key outcome measure of interest to regulatory authorities such as the FDA.