Alterity to Deliver Multiple Presentations at MDS Conference
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Alterity Therapeutics to Deliver Multiple Presentations at the 2025 International
Congress of Parkinson’s Disease and Movement Disorders
– Data from ATH434-201 double-blind Phase 2 trial to be featured in oral session and multiple
poster presentations –
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 2 October 2025: 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 atthe 2025InternationalCongress ofParkinson’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 educatingleaders in the movement disorder communityon its potentialas 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: ATH434Slowed DiseaseProgression in a Phase2Study in MultipleSystemAtrophy
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 Phase2 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 implicatedin neurodegeneration.ATH434has been shown preclinicallyto
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 demonstratedthe agent is well tolerated and achieved brain levels
comparable to efficacious levels in animal models ofMSA. Positive results from the randomized,
double-blind,placebo-controlledPhase 2 clinical trial in patients with MSA demonstratedrobust
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
includingtrends in improvedmotor performance on the Parkinson’s Plus ratingscale,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 ofthe symptoms ofMSA 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
AlterityTherapeutics is a clinicalstage biotechnologycompanydedicated to creatingan alternate
future for people livingwith neurodegenerative diseases. The Company is initially focused on
developingdisease modifyingtherapies in Parkinson’s disease and relateddisorders.Alterityhas
demonstrated clinicallymeaningful 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,Alterityhas a broad drug
discoveryplatform generatingpatentable chemicalcompoundsto treat the underlyingpathology
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 section21E 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 withthe 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 limitedtothe 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 limitedto,ATH434,that could slowor 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 topublicly update any forward-looking statement,whether writtenor oral, that may
be made from time to time, whether as a result of new information, future developments or
otherwise.
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