MELBOURNE,
Australia, Nov. 9, 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 a poster presentation and
accompanying video were delivered at the American Autonomic Society
32nd Annual Internation Symposium on the Autonomic
Nervous System.
The poster, entitled, Cardiovascular safety and
pharmacokinetics of ATH434, a novel small molecule inhibitor of
α-synuclein aggregation, in adults and older adults, described
results from the Company's Phase 1 clinical trial conducted in
healthy volunteers. In the Phase 1 trial, ATH434 was well tolerated
in adult and ≥ 65 year-old volunteers and demonstrated no cardiac
adverse event signal and no clinically significant changes in blood
pressure or heart rate at any dose. ATH434 also demonstrated dose
dependent pharmacokinetics (PK) after single and multiple oral
doses and a half-life that supports twice-daily dosing.
"The promising safety profile and oral bioavailability of ATH434
supports our Phase 2 clinical trial design in patients with
multiple system atrophy (MSA)," said David
Stamler, M.D., Chief Executive Officer, Alterity. "We
believe that the option for administration in pill form may provide
a convenient treatment option for individuals with MSA. We
look forward to initiating our Phase 2 clinical trial in MSA in the
first quarter of next year."
In addition, Daniel Claassen, MD,
gave a plenary lecture on the imaging methods for MSA which
included findings from Alterity's Biomarkers of progression in
Multiple System Atrophy (bioMUSE) natural history study, available
here. Dr. Claasen is Associate Professor of Neurology, Vanderbilt University Medical Center and Principal
Investigator of bioMUSE.
Alterity's poster presentation and accompanying video will be
available on the Company's website.
About ATH434
Alterity's lead candidate, ATH434, is the first of a new
generation of small molecules designed to inhibit the aggregation
of pathological proteins implicated in neurodegeneration. ATH434
has been shown preclinically to reduce α-synuclein pathology and
preserve nerve cells by restoring normal iron balance in the brain.
In this way, it has excellent potential to treat Parkinson's
disease as well as various forms of atypical Parkinsonism such as
Multiple System Atrophy (MSA). ATH434 has successfully completed a
Phase 1 clinical trial demonstrating the agent is well tolerated,
orally bioavailable, and achieved brain levels comparable to
efficacious levels in animal models of MSA, with the objective of
restoring function in patients with MSA and other Parkinsonian
disorders.
ATH434 has been granted Orphan designation for the treatment of
MSA by the U.S. FDA and the European Commission.
About bioMUSE
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 a combination of symptoms that affect
both the autonomic nervous system and 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 motor impairment, 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
α-synuclein within 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 is
no cure.1
1National Institute of Health: Neurological Disorders
and Stroke, Multiple System Atrophy Fact Sheet
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.
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 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.
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SOURCE Alterity Therapeutics Limited