Australia now open for study
of rare, rapidly progressive Parkinsonian Disorder
MELBOURNE, Australia and SAN FRANCISCO, Oct. 13,
2022 /PRNewswire/ -- 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 it has
received approval in Australia
from the St. Vincent's Hospital Melbourne Human Research Ethics
Committee (HREC) to conduct the Phase 2 clinical trial of
ATH434 for the treatment of individuals with Multiple System
Atrophy (MSA). Alterity has also opened enrolment at its first
clinical trial site in Sydney.
"We are thrilled to receive ethics approval and launch our first
clinical trial site for enrolment in Australia," said David
Stamler, M.D., Chief Executive Officer, Alterity. "ATH434 is
designed to slow the progression of MSA and we are eager to
increase access to our study of this potential disease modifying
treatment. Our Phase 2 program has now received regulatory
authorization in five countries with three locations actively
recruiting participants in the trial."
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled investigation of ATH434 in patients with
early-stage MSA. The study will explore the effect of ATH434
treatment on neuroimaging and protein biomarkers, such as excess
brain iron and aggregating α-synuclein, which are important
contributors to MSA pathology. Clinical endpoints will permit
comprehensive assessment of ATH434 efficacy along with
characterization of safety and pharmacokinetics. The use of
wearable sensors will allow evaluation of motor parameters that are
important in patients with MSA. The study is expected to enroll
approximately 60 adult patients to receive one of two dose levels
of ATH434 or placebo. Patients will receive treatment for 12 months
which will provide an opportunity to detect changes in efficacy
endpoints to optimize design of a definitive Phase 3 study.
Additional information on the Phase 2 trial can be found by
ClinicalTrials.gov Identifier: NCT05109091.
About ATH434
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
α-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.
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 α-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 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 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.
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