Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International Congress of Parkinson’s Disease and Movement Disorders

Rhea-AI Summary

Alterity Therapeutics (NASDAQ: ATHE) announced multiple presentations of data from their ATH434-201 Phase 2 clinical trial in Multiple System Atrophy (MSA) at the upcoming 2025 International Congress of Parkinson's Disease and Movement Disorders in Honolulu.

The presentations include an oral platform presentation by CEO David Stamler on how ATH434 slowed disease progression in MSA, and two poster presentations focusing on alpha-synuclein aggregation profiles and clinical/imaging phenotypes. The congress will take place from October 5-9, 2025.

The company aims to educate movement disorder experts about ATH434's potential as a first-ever treatment for MSA.

Insights

Biotechnology Clinical Trial Analyst

Alterity's Phase 2 trial results show ATH434 slowed MSA progression - a potential breakthrough for an untreatable neurodegenerative disease.

This announcement represents a significant milestone for Alterity Therapeutics as they prepare to present positive Phase 2 clinical trial results for ATH434 in Multiple System Atrophy (MSA) at the upcoming International Congress of Parkinson's Disease and Movement Disorders. The oral presentation title explicitly states that "ATH434 Slowed Disease Progression" - a critical outcome for a neurodegenerative condition that currently lacks approved disease-modifying treatments.

MSA is a rare, rapidly progressive neurodegenerative disorder characterized by autonomic dysfunction, parkinsonism, and cerebellar ataxia. What makes these results particularly noteworthy is the CEO's statement regarding ATH434's "potential as a first-ever treatment for MSA." Achieving disease-slowing effects in MSA would address a substantial unmet medical need.

The comprehensive presentation approach - featuring an oral platform presentation plus two supporting poster presentations - suggests robust data. The posters examining alpha-synuclein aggregation profiles, imaging biomarkers, and clinical/imaging phenotypes indicate the company has gathered meaningful mechanistic and biomarker data to support their clinical findings. This multi-faceted approach strengthens the scientific validity of their results.

For a small biotechnology company focused on neurodegenerative diseases, positive Phase 2 results in a condition with no approved treatments represents a potential inflection point in their clinical development program and could significantly enhance the probability of regulatory success.

– Data from ATH434-201 double-blind Phase 2 trial to be featured in oral session and multiple poster presentations –

MELBOURNE, Australia and SAN FRANCISCO, Oct. 02, 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) will be featured at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS) taking place October 5-9, 2025 in Honolulu, HI, USA.

“We look forward to presenting data from the Phase 2 double-blind clinical trial of ATH434 at MDS 2025 and educating leaders in the movement disorder community on its potential as a first-ever treatment for MSA,” said David Stamler, M.D., Chief Executive Officer of Alterity.

Type:		Oral Platform Presentation
Session:		Atypical and Other Parkinsonisms
Title:		ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy
Presenter:		David Stamler, M.D., Chief Executive Officer, Alterity
Date/Time:		Wednesday, October 8, 2025, 12:00-1:00p HST

Type:		Poster Presentation
Title:		Relationship Between Alpha-Synuclein Aggregation Profiles, Imaging Biomarkers, and Disease Severity in a Phase 2 Study of ATH434 in MSA
Presenter:		Margaret Bradbury, Ph.D., Vice President, Nonclinical Development, Alterity
Date/Time:		Sunday, October 5, 2025, 12:00p – 3:00p HST

Type:		Poster Presentation
Title:		Differences Between Clinical and Imaging Phenotypes in Phase 2 Study of ATH434 in Multiple System Atrophy
Presenter:		Paula Trujillo, PhD, Research Assistant Professor, Department of Neurology, Vanderbilt University Medical Center
Date/Time:		Sunday, October 5, 2025, 12:00p – 3:00p HST

About ATH434

Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). Phase 1 studies have demonstrated the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. Positive results from the randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated robust clinical efficacy, target engagement on key biomarkers, and a favorable safety profile. Positive data from a second Phase 2 open-label biomarker trial in patients with more advanced MSA reinforced these results. ATH434 has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation by the FDA and the European Commission for the treatment of MSA.

About ATH434-201 Phase 2 Clinical Trial

The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of 12 months treatment with ATH434 in patients with MSA. The study evaluated the efficacy, safety and pharmacokinetics of ATH434 as well as the effect of ATH434 on neuroimaging and protein biomarkers. Wearable sensors were employed to evaluate motor activities outside of the clinic. The study enrolled 77 adults who were randomly assigned to receive ATH434 50 mg or 75 mg twice daily or matching placebo. The data showed that, compared to placebo, ATH434 produced clinically and statistically significant improvement on the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I, a functional rating scale that assesses disability on activities of daily living affected in MSA. Additional efficacy assessments demonstrated improvement consistent with the positive UMSARS Part I findings including trends in improved motor performance on the Parkinson’s Plus rating scale, the Clinical Global Impression of Severity Scale, and the Orthostatic Hypotension Symptom Assessment (a patient reported outcome). Wearable sensor data indicated that ATH434 also led to increased activity in an outpatient setting. Biomarkers were used to evaluate potential drug effect and target engagement relative to placebo. Both dose levels reduced iron accumulation in MSA affected brain regions with trends in preservation of brain volume. ATH434 was well tolerated with similar adverse event rates compared to placebo and no serious adverse events attributed to ATH434. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.

About Multiple System Atrophy

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects up to 50,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.¹

¹Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)

About Alterity Therapeutics Limited

Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company is initially focused on developing disease modifying therapies in Parkinson’s disease and related disorders. Alterity has demonstrated clinically meaningful efficacy for its lead asset, ATH434, in a randomized, double-blind, placebo-controlled Phase 2 clinical trial in participants with Multiple System Atrophy (MSA), a rare and rapidly progressive Parkinsonian disorder. ATH434 recently reported positive data in its open label Phase 2 clinical trial in advanced MSA. In addition, Alterity has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s website at www.alteritytherapeutics.com.

Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.

Contacts:

Investors
Remy Bernarda
Investor Relations Advisory Solutions
ir@alteritytx.com
+1 (415) 203-6386

Media
Casey McDonald
Tiberend Strategic Advisors, Inc.
cmcdonald@tiberend.com
+1 (646) 577-8520

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

FAQ

When and where will Alterity Therapeutics (ATHE) present their Phase 2 MSA trial data?

Alterity will present at the International Congress of Parkinson's Disease and Movement Disorders in Honolulu, from October 5-9, 2025, featuring both oral and poster presentations.

What are the key presentations for Alterity's ATH434 Phase 2 trial at the 2025 Movement Disorders Congress?

The presentations include an oral platform presentation on ATH434's effect on disease progression by CEO David Stamler, and two poster presentations focusing on alpha-synuclein aggregation profiles and clinical/imaging phenotypes.

Who are the presenters for Alterity Therapeutics' ATH434 data at the 2025 MDS Congress?

The presenters include David Stamler, M.D. (CEO), Margaret Bradbury, Ph.D. (VP of Nonclinical Development), and Paula Trujillo, PhD (Research Assistant Professor at Vanderbilt University Medical Center).

What is the potential significance of Alterity's ATH434 for Multiple System Atrophy (MSA)?

ATH434 is being developed as potentially the first-ever treatment for Multiple System Atrophy (MSA), with Phase 2 trial data showing effects on disease progression.