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 an independent Data Monitoring Committee (DMC) has
completed its second review of trial data and recommended the
ATH434-201 Phase 2 study continue as planned. The ATH434-201
clinical trial is a randomized, double-blind, placebo-controlled
investigation of ATH434 in patients with early-stage multiple
system atrophy (MSA), a rare neurodegenerative disease with no
approved treatments to slow or stop its progression.
The DMC conducted its second prespecified review
of unblinded clinical data from study participants. The DMC
expressed no concerns about safety and recommended that the study
continue without modification. The plan for the DMC to review
initial safety data has been cleared with the U.S. Food and
Drug Administration.
“With accumulated data from our Phase 2 study,
we are pleased to report that the Data Monitoring Committee has
determined that there are no safety concerns and that the study can
continue as planned,” said David Stamler, M.D., Chief Executive
Officer of Alterity. “Participants in the trial are being dosed for
12 months; therefore, this recommendation is an important milestone
as participants able to safely tolerate ATH434 as their time on
study increases. We remain on track to complete the study in
November 2024 and report top-line data in January 2025.”
The ATH434-201 Phase 2 clinical trial is
evaluating 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. Selected biomarkers, such as brain
iron and aggregating α-synuclein, are important contributors to MSA
pathology and are therefore appropriate targets to demonstrate drug
activity. Wearable sensors have also been employed to evaluate
motor activities that are important to patients with MSA. The study
enrolled 77 adults who were randomly assigned 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.
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 neuronal
function 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 two clinical trials: Study ATH434-201 is
a randomized, double-blind, placebo-controlled Phase 2 clinical
trial in patients with early-stage MSA and Study ATH434-202 is an
open-label Phase 2 Biomarker trial in patients with more advanced
MSA. ATH434 has been granted Orphan drug 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 at
least 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 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 informationThis
announcement was authorized by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
AustraliaHannah
Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648
064
U.S.Remy Bernardaremy.bernarda@iradvisory.com
+1 (415) 203-6386
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,
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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