Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International Congress of Parkinson's Disease and Movement Disorders
MWN-AI** Summary
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is poised to present significant data from its Phase 2 clinical trial of ATH434 at the 2025 International Congress of Parkinson’s Disease and Movement Disorders in Honolulu, Hawaii, from October 5-9. The ATH434-201 trial, a randomized, double-blind, placebo-controlled study, focuses on the treatment of Multiple System Atrophy (MSA), a rare neurodegenerative disease lacking effective therapies that can slow disease progression.
David Stamler, M.D., CEO of Alterity, will deliver an oral presentation on October 8, outlining how ATH434 has demonstrated the potential to slow the disease's progression. Additionally, three poster presentations will provide further insights, including the relationship between alpha-synuclein aggregation and disease severity, led by Margaret Bradbury, Ph.D., and clinical versus imaging phenotype differences presented by Paula Trujillo, Ph.D.
ATH434 functions as an iron chaperone to inhibit the aggregation of pathological proteins linked to neurodegeneration. It has shown promise in preclinical and Phase 1 studies, achieving brain levels comparable to those necessary for efficacy in animal models. The Phase 2 trial enrolled 77 participants, revealing clinically significant improvements in disability ratings through wearable sensors, alongside favorable safety data.
With Fast Track Designation and Orphan Drug Designation from the FDA and European Commission, respectively, ATH434's efficacy in treating MSA positions Alterity Therapeutics as a key player in neurodegenerative disease treatment. The upcoming congress presentations aim to educate the movement disorder community on the promising results of ATH434, furthering the conversation on therapeutic advancements for MSA.
MWN-AI** Analysis
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) is poised for significant attention as it presents pivotal data on ATH434 from its Phase 2 trial for Multiple System Atrophy (MSA) at the upcoming International Congress of Parkinson's Disease and Movement Disorders. The dual presentation format—an oral session and several poster presentations—highlights the importance of these findings to the neurology community and potential investors.
The Phase 2 trial demonstrated robust efficacy for ATH434, suggesting its ability to slow disease progression, which is crucial in a therapeutic landscape marked by a lack of effective treatments for MSA. The favorable safety profile, coupled with the drug's ability to engage key biomarkers, positions Alterity favorably in the eyes of both clinicians and potential partners. Investors should note that the company has received Fast Track and Orphan Drug Designations from the FDA, which could expedite ATH434's development pathway and market entry.
Additionally, the ongoing conversations within the medical community regarding the implications of reduced alpha-synuclein aggregation could lead to increased interest and collaborations. Given that MSA affects up to 50,000 individuals in the U.S. alone, the market opportunity for ATH434 is substantial, especially as the disease is characterized by debilitating symptoms yet lacks disease-modifying therapies.
From a market perspective, Alterity's upcoming presentations present a strategic opportunity for investors. If positive data is corroborated in peer discussions, it may catalyze upward momentum in the stock price. Stakeholders should monitor the reactions from the congress closely, as sustained investor enthusiasm could require navigating through any anticipated volatility surrounding clinical trial outcomes. In conclusion, bullish sentiment could prevail, particularly if the presentations reinforce ATH434's promising efficacy and safety profile. Investors should consider leveraging this momentum while remaining cognizant of the inherent risks in biotechnology investments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
– 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 ?-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 ?-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
1 Multiple 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**
What specific metrics did the ATH434-201 Phase 2 trial use to evaluate the efficacy of ATH434 in improving patient outcomes in Multiple System Atrophy (MSA) based on the data from Alterity Therapeutics Limited ATHE?
How does the relationship between alpha-synuclein aggregation and disease severity influence the outcomes reported in the Phase 2 trial of ATH434, as highlighted by Alterity Therapeutics Limited ATHE?
Given the promising results and positive safety profile of ATH4in the Phase 2 trial, what are the next steps Alterity Therapeutics Limited ATHE plans to take for further clinical development and potential regulatory approvals?
How has the FDA's Fast Track and Orphan Drug Designation impacted Alterity Therapeutics Limited ATHE’s strategic planning for ATH434's commercialization and patient access for MSA treatments?
**MWN-AI FAQ is based on asking OpenAI questions about Alterity Therapeutics Limited (NASDAQ: ATHE).
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