Full Press Release Details
Alterity Therapeutics Announces
New Publication Describing Novel Mechanism of Action for ATH434
- Peer-Reviewed Publication Describes
How ATH434 Uniquely Targets Excess Iron -
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 6 November 2024: 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
peer-reviewed journal, Metallomics has published data on the importance of iron and iron-targeting agents like ATH434 to treat
neurodegenerative diseases. Metallomics publishes cutting-edge investigations that elucidate the dynamics, role, and impact of
metals in biological systems.
David Stamler, M.D., Chief Executive
Officer of Alterity, commented, "Iron has long been implicated in neurodegeneration, but having the appropriate iron-targeting agent
is critical to having a positive impact on treating disease. This ground-breaking publication demonstrates the novel way in which ATH434
targets the labile, or reactive, form of iron which can be so damaging to cells when in excess. ATH434 acts as an iron chaperone to redistribute
this excess reactive iron, thereby reducing protein aggregation and oxidative stress in the brain and rescuing neuronal function."
The publication, entitled, "ATH434,
a promising iron-targeting compound for treating iron regulation disorders" was led by author Ashley Pall, Department of Pharmaceutical
Sciences at Wayne State University. The novel iron binding properties of ATH434 presented in the publication support the characterization
of ATH434 as an iron chaperone. The publication describes how ATH434 targets the toxic form of iron that drives the pathology of a rare
neurodegenerative disease known as Friedreich's Ataxia. This toxic form of iron is also involved in the pathogenesis of Parkinson's
disease and multiple system atrophy (MSA), which is the company's lead indication.
The study also evaluated iron
chelators that are designed to irreversibly bind the stored form of iron and remove it from the body. Specifically, the study
investigated how strongly ATH434 or iron chelators bind the two forms of cellular iron: ferric iron, the stored form, or ferrous
iron, the active form required for vital cellular functions such as energy production but which is associated with toxicity when in
excess. The new data confirmed that ATH434 has a dramatically lower affinity for ferric iron than iron chelators which are approved
for treating systemic iron overload. ATH434's binding is reversible and will not remove iron from the body. The study also
confirmed an undesirable property of iron chelators: They promote conversion of ferrous to ferric iron, generating damaging free
radicals in the process. In comparison, ATH434 was significantly less likely to drive this reaction. Together, these properties
suggest that ATH434 has the capacity to selectively target the pathogenic form of iron without impairing normal cellular iron
trafficking or functions.
Access to the abstract and full publication
are available here. (1)
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.
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). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain
levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201
is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label
Phase 2 Biomarker trial in patients with more advanced MSA. ATH434 has been granted Orphan drug designation for the treatment of MSA by
the U.S. FDA and the European Commission.
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's
lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical
trials in Multiple System Atrophy. Alterity also 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 web site at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
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.