Full Press Release Details
Alterity Therapeutics Launches
ATH434 Phase 2 Clinical Trial in Australia for the Treatment of Individuals with Multiple System Atrophy
Australia now open for study of rare, rapidly progressive
Parkinsonian Disorder
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 13 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 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 -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.
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.
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 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
This announcement was authorized by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
Remy Bernarda remy.bernarda@iradvisory.com
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.
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 nothistorical 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.
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.