Granted New U.S. Composition of Matter Patent for ATH434
Released
Released
Announcement PDF
Alterity Therapeutics Announces Granting of New U.S. Composition of Matter Patent
for ATH434
– Newly granted patent extends protection for ATH434 to at least 2045,
significantly enhancing its strategic value and long-term commercial potential –
– Strengthens ATH434’s intellectual property portfolio as it advances toward Phase 3 development in
Multiple System Atrophy –
– Enables future development of ATH434 for Parkinson’s disease
and other major neurodegenerative disorders –
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 12 August 2026: 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 the United States Patent and
Trademark Office (USPTO) has granted a new composition of matter patent for ATH434, the Company’s lead
clinical asset. ATH434 is an oral agent designed to treat the underlying pathology of neurodegenerative diseases
such as Multiple System Atrophy (MSA), Parkinson’s disease and related disorders. The newly granted patent
represents a significant intellectual property milestone for Alterity and strengthens ATH434’s long-term
commercial potential as the Company prepares to initiate Phase 3 trial activities in MSA by year-end 2026.
The new patent provides composition-of-matter protection for a crystalline structure of the mesylate salt form
of ATH434 as well as protection for methods for treating neurological conditions using it. This form of ATH434
was used in the Company’s Phase 2 clinical trials in MSA and will be utilized in the planned Phase 3 study. The
patent extends protection for ATH434 to at least 2045, and together with existing intellectual property (IP) and
regulatory designations, provides multi-layered market protection. In addition to reinforcing Alterity’s position
in MSA, the new patent enables future development opportunities for ATH434 in Parkinson’s disease and other
neurodegenerative diseases where iron dysregulation and protein aggregation are implicated.
“With protection to at least 2045, this patent extends the commercial life and revenue potential for ATH434 in
MSA, if approved, as we prepare to initiate Phase 3 trial activities by year-end 2026,” said David Stamler, M.D.,
Chief Executive Officer. “Importantly, Parkinson’s disease is now a viable target indication for ATH434, as our
strengthened IP provides the protection needed to justify investment in this major neurodegenerative disorder.
The granting of this new U.S. composition of matter patent reflects the deliberate execution of our IP strategy
and is one of the most critical steps we have taken to protect the innovation behind ATH434.”
“Overall, this patent enhances the strategic value of ATH434, supporting potential partnerships and other
opportunities to advance development. We remain dedicated to developing ATH434 as a disease modifying
treatment for these debilitating conditions,” concluded Dr. Stamler.
New Composition of Matter Patent for ATH434
The USPTO granted the patent entitled "Crystalline Form, and Process for its Production" which covers the
composition of matter of a crystalline form of ATH434 mesylate as well as methods for treating neurological
conditions using it. The allowed claims protect the novel solid-state crystalline form of ATH434 mesylate and
treatment methods, providing another layer of protection as a commercial asset for the treatment of MSA and
additional neurodegenerative diseases.
The patent has an estimated expiration date of at least 2045 and is expected to be listed in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations publication (the “Orange Book”), upon regulatory
approval of ATH434 for commercialization.
Composition of matter claims are widely recognized as one of the strongest forms of pharmaceutical patent
protection.
About ATH434
Alterity’s lead candidate, ATH434, is an oral agent designed to reduce iron accumulation and inhibit abnormal
protein aggregation associated with neurodegeneration. ATH434 has been shown to reduce α-synuclein
pathology and preserve neuronal function by restoring normal iron balance in the brain in preclinical models.
With properties shared by endogenous iron chaperones, it has the potential to treat Parkinson’s disease as well
as various Parkinsonian disorders such as Multiple System Atrophy (MSA). Positive results from the randomized,
double-blind, placebo-controlled Phase 2 clinical trial in patients with MSA demonstrated clinically meaningful
efficacy, target engagement as indicated by 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 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 that causes profound
disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or
rigidity, autonomic dysfunction affecting involuntary functions such as blood pressure maintenance and bladder
control, and impaired balance and/or coordination that predispose patients to falls. A pathological hallmark of
MSA is the accumulation of abnormal clumping of the protein α-synuclein within oligodendrocytes, the myelin-
producing support cells of the central nervous system, along with progressive neuronal 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
About Parkinson’s Disease
Parkinson's disease (PD) is the second most common neurodegenerative disorder and causes unintended or
uncontrollable movements of the body along with neuropsychiatric and other nonmotor features. The precise
cause of PD is unknown, but some cases are hereditary while others are thought to occur from a combination
of genetics and environmental factors that trigger the disease. In PD, brain cells become damaged or die in the
substantia nigra, the part of the brain that produces dopamine – a chemical needed to produce smooth,
purposeful movement. The cardinal symptoms of PD are tremors, rigidity, slowing of movements, and later in
disease, impaired balance. Other symptoms may include difficulty swallowing, chewing, or speaking; emotional
changes; urinary problems or constipation; dementia or other cognitive problems; fatigue; and problems
sleeping.2
Nearly one million people in the U.S. and more than 10 million people worldwide are living with PD.
Approximately 60,000 Americans are diagnosed with PD each year.3
References
1 Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)
2 National Institute of Health: Neurological Disorders and Stroke, Parkinson's Disease Information Page;
3 Parkinson’s Foundation
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 focused on developing disease modifying
therapies in Multiple System Atrophy (MSA) and related Parkinsonian disorders. Alterity is preparing to initiate
a Phase 3 pivotal trial in MSA, a rare and rapidly progressive disease. ATH434, the Company’s lead asset, has
demonstrated clinically meaningful efficacy in a randomized, double-blind, placebo-controlled Phase 2 clinical
trial in participants with MSA. Alterity has further reported positive data in its open label Phase 2 clinical trial in
participants with 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 https://alteritytx.com.
Authorization & Additional information
This announcement was authorized by the Board of Directors of Alterity Therapeutics Limited.
Contacts:
Investors
Elyse Shapiro
ir@alteritytx.com
Remy Bernarda
Investor Relations Advisory Solutions
ir@alteritytx.com
+1 (415) 203-6386
Media
Melissa Tempra
NWR Communications
melissa@nwrcommunications.com.au
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 speaksonlyasofthedateonwhichitismade.Weundertakeno obligationtopubliclyupdate
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.
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