Full Press Release Details
Alterity Therapeutics Enrols First Patient
in the United Kingdom in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 4 April 2023: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"),
a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the
first participant has been dosed in the United Kingdom in the Company's Phase 2 clinical trial of ATH434 in Multiple System
"MSA is a rare and highly debilitating Parkinsonian
disorder, and our Phase 2 clinical program is designed to evaluate the effects of ATH434 in individuals with early-stage disease with
no current therapeutic treatment options," said David Stamler, M.D., Chief Executive Officer, Alterity. "With sites open in
five countries, the clinical trial is steadily enrolling globally, and the enrollment of our first patient in the United Kingdom expands
our reach in Europe."
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on
neuroimaging and protein biomarkers to demonstrate target engagement, and clinical endpoints to demonstrate efficacy, in addition to assessments
of safety and pharmacokinetics. The selected biomarkers, including brain iron and aggregating -synuclein, are important contributors
to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors will also be employed to evaluate
motor activities that are important to patients with MSA. The study is expected to enroll approximately 60 adults to receive one of two
dose levels of ATH434 or placebo. Participants 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 is currently being studied in a randomized, double-blind, placebo-controlled Phase 2 clinical trial
in patients with early-stage MSA. ATH434 has been granted Orphan designation for the treatment of MSA by the U.S. FDA and the European
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
1Multiple System Atrophy | National
Institute of Neurological Disorders and Stroke (nih.gov)
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
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.
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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.