MELBOURNE, Australia,
July 15, 2021 /PRNewswire/ --
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the
Company"), a biotechnology company dedicated to developing disease
modifying treatments for neurodegenerative conditions, today
announced that Movement Disorders, the official journal of
the International Parkinson and Movement Disorder Society, has
published results from a study demonstrating that ATH434 reduces
α–synuclein related neurodegeneration in a widely accepted murine
model of Multiple System Atrophy (MSA)[1].
"The publication of data demonstrating that ATH434 preserves
neurons while reducing α–synuclein in areas of pathology is exactly
what we were hoping to see as we advance to clinical trials in
MSA," said Alterity Chief Executive Officer David Stamler, M.D.,. "By targeting α–synuclein
and excess brain iron in MSA, we believe that ATH434 can treat the
underlying cause of this devastating disease which has no approved
therapy. We remain on track to initiate our Phase 2
clinical trial of ATH434 in patients with MSA by the end of the
calendar year."
The study was performed at the Laboratory for Translational
Neurodegeneration Research, Department of Neurology, Medical
University of Innsbruck in Austria, a leading laboratory of animal
research in MSA, under the direction of Professor Nadia Stefanova.
The preclinical study showed that treatment with ATH434 was
neuroprotective and improved motor function, independently
confirming and extending previous findings from another academic
laboratory, both in the same MSA model as well as animal models of
Parkinson's Disease.[2],[3] In preserving neurons,
ATH434 reduced both the aggregated form of α–synuclein and the
so-called toxic oligomeric form, which is thought to underlie the
spreading of disease to other neurons. At the same time,
ATH434 significantly reduced brain iron in areas of pathology,
consistent with its mechanism of action.
Beyond these observations, the study also revealed for the first
time that ATH434 preserved neurons in a region of the brain, called
the striatum, that is known to be affected in patients with MSA.
Importantly, ATH434 improved performance on diverse motor tests,
including a beneficial effect on the "challenging beam" task, which
is used to assess balance. This latter finding is especially
relevant to patients with MSA, where impaired balance is a major
source of disability.
The full publication can be found at the Movement
Disorders journal website: http://doi.org/10.1002/mds.28714
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare, neurodegenerative
disease with no approved therapy. It is rapidly
progressive and causes profound disability. MSA is a Parkinsonian
disorder characterized by motor impairment typical of Parkinson's
disease; autonomic instability that affects involuntary functions
such as blood pressure maintenance and bladder control; and
impaired balance and/or coordination that predisposes to falls. MSA
affects approximately 15,000 patients in the U.S. A pathological
hallmark of MSA is the accumulation of α-synuclein within
oligodendroglia cells (glial cytoplasmic inclusions) and neuron
loss in multiple brain regions.
About ATH434
ATH434 is the first of a new generation of small molecule drug
candidates designed to inhibit the accumulation and aggregation of
pathological proteins implicated in neurodegeneration.
Alpha-synuclein is a neuronal protein that aggregates in neurons
and is considered an important biologic target for treating these
neurodegenerative diseases. ATH434 has been shown to reduce
abnormal accumulation of α–synuclein protein in animal models of
disease by restoring normal iron balance in the brain. As a result,
it has the potential to treat various disorders including Multiple
System Atrophy (MSA), Parkinson's Disease, and Dementia with Lewy
Bodies (DLB). ATH434 has been granted Orphan designation for the
treatment of MSA by the U.S. Food and Drug Administration and the
European Union.
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 forms of
Parkinsonian disorders. Alterity also has a broad drug discovery
platform generating patentable chemical to intercede in disease
processes. 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.
Contact: Investor Relations
Australia
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US
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Rebecca
Wilson
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Remy
Bernarda
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E:
WE-AUAlterity@we-worldwide.com
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remy.bernarda@iradvisory.com
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Tp: +61 417 382
391
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Tp: +1 (415)
203-6386
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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, uncertainties
relating to the impact of the novel coronavirus (COVID-19) pandemic
on the company's business, operations and employees, 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 patent protection for the Company's intellectual
property or trade secrets, including, but not limited to, the
intellectual property relating to ATH434.
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.
[1]
Heras-Garvin A, Refolo V, Schmidt C, et al. ATH434 Reduces
α-Synuclein-Related Neurodegeneration in a Murine Model of Multiple
System Atrophy. Mov Disord. 2021 Jul 8. doi:
10.1002/mds.28714. Epub ahead of print. PMID: 34236731.
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[2]
Finkelstein D, Stefanova N, Adlard P, et al. PBT434
Prevents α-synuclein Aggregation, Neuron Loss, Motor Dysfunction
and Reduces Glial Cell Inclusions in a Transgenic Mouse Model of
Multiple System Atrophy (P5.8-006). Neurology Apr
2019, 92 (15 Suppl) P5.8-006.
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[3]
Finkelstein, D.I., Billings, J.L., Adlard, P.A. et
al. The novel compound PBT434 prevents iron mediated
neurodegeneration and alpha-synuclein toxicity in multiple models
of Parkinson's disease. Acta Neuropathol
Commun 5, 53 (2017).
https://doi.org/10.1186/s40478-017-0456-2
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SOURCE Alterity Therapeutics Limited