Full Press Release Details
Alterity Therapeutics Announces Presentation
of MRI Data from the bioMUSE Natural History Study at the American Neurological Association Annual Meeting
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA
- 26 October 2022: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology
company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced a poster presentation from
the ongoing Biomarkers of Progression in Multiple System Atrophy (bioMUSE) natural history study was given at the 147th Annual
Meeting of the American Neurological Association (ANA) on October 24, 2022. For over 140 years, the ANA has been the premier professional
society of academic neurologists and neuroscientists devoted to understanding and treating diseases of the nervous system.
The presentation evaluated different methods of
measuring the volume of brain structures affected in individuals with Multiple System Atrophy (MSA) and Parkinson's disease versus
healthy controls. The poster, entitled Deep Learning Segmentation Improves Precision of Volume Assessment of Subcortical Structures
in early MSA, evaluated the accuracy of MRI scans on three different areas of the basal ganglia section of the brain utilizing three
different techniques.
"Our bioMUSE natural history study continues
to produce meaningful data to guide our Phase 2 trial by providing valuable insight into the diagnosis and biomarkers of MSA," said
David Stamler, M.D., Chief Executive Officer, Alterity. "In particular, the poster presented at ANA found meaningful differences
in methods to measure brain volume in MSA patients. This work will allow for greater precision in defining affected brain structures,
an essential step for quantifying changes in MSA, such as tissue atrophy and iron deposition."
The study enrolled 21 individuals with early stage
MSA based on neurological assessment. The study concluded that deep-learning segmentation, a form of artificial intelligence, outperforms
the commonly used methods FSL-FIRST and Joint Label Fusion for analyzing brain MRI scans in MSA patients. This improvement was observed
in subcortical brain regions with notable MSA pathology. MSA-related pathological changes hinder the precision of automatic segmentation
from FSL-FIRST. In addition, in early MSA, significant reductions in putamen and pallidum volume were observed compared to healthy controls,
and in pallidum volume compared to Parkinson's disease.
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 nerve cells 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 has been granted Orphan designation for the treatment
of MSA by the U.S. FDA and the European Commission.
Biomarkers of progression in Multiple System Atrophy
(bioMUSE) is an ongoing, natural history study that aims to track the progression of patients with MSA, a Parkinsonian disorder without
approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under the direction
of Daniel Claassen, MD, Associate Professor of Neurology and Principal Investigator. Natural history studies are important for characterizing
disease progression in selected patient populations. The study has provided rich data for optimizing the design of Alterity's Phase
2 clinical trial and will be expanded to include a total of 20 patients with MSA. The ongoing study will continue to provide vital information
on early stage MSA patients, inform the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy, and deliver
clinical data to characterize disease progression in a patient population that mirrors those to be enrolled in the Phase 2 clinical trial.
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 -synuclein within glia, the support cells of the central
nervous system, and neuron loss in multiple brain regions. MSA affects approximately 15,000 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
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. Alterity also has a broad drug discovery platform generating patentable chemical
compounds 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.
Investor and Media Contacts:
Forward Looking Statements
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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,"
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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 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.
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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.