– 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, Aug. 12, 2026 (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 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
[email protected]
Remy Bernarda
Investor Relations Advisory Solutions
[email protected]
+1 (415) 203-6386
Media
Melissa Tempra
NWR Communications
[email protected]
Casey McDonald
Tiberend Strategic Advisors, Inc.
[email protected]
+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
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Important
factors
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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
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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
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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.
