Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the
Company”), a biotechnology company dedicated to developing disease
modifying treatments for neurodegenerative diseases, today
announced it has commenced a new Phase 2 clinical trial of ATH434
in patients with Multiple System Atrophy (MSA) and the first
patient has been enrolled. This open label study, entitled “A
Biomarker Study of ATH434 in Participants with MSA”
(ATH434-202) is in addition to the ongoing, randomized,
double-blind, placebo-controlled Phase 2 trial in early-stage MSA
(ATH434-201).
The Biomarker trial will enroll approximately 15
individuals with more advanced MSA than those participating in the
randomized trial. A key aim of the study is to assess the efficacy
of ATH434 on objective biomarkers that measure target engagement
and are relevant to the underlying pathology of disease. Clinical
measures important in MSA will also be assessed.
“This Phase 2 Biomarker study complements our
ongoing randomized Phase 2 trial, allowing us to evaluate the
effect of ATH434 on two MSA populations of differing severity,”
said David Stamler, M.D., Chief Executive Officer, Alterity.
“Individuals with more advanced MSA may also benefit from ATH434
and measuring key biomarkers will permit us to evaluate drug
activity in this population. The data derived from these two trials
will help us optimize and potentially accelerate future
development.”
“Importantly, the randomized Phase 2 trial is
proceeding as planned, but the design of this new study will allow
us to perform interim analyses of biomarker data during conduct,
which could give us early indications of efficacy. We expect to
have preliminary data from an initial cohort of enrolled
participants before the randomized study reads out,” added Dr.
Stamler.
ATH434-202 study participants will receive
treatment with ATH434 for 12-months. The study will assess the
effect of ATH434 treatment on neuroimaging and protein biomarkers
to evaluate target engagement, in addition to clinical measures,
safety, and pharmacokinetics. The selected biomarkers, including
brain iron and aggregating α-synuclein, are important contributors
to MSA pathology and are appropriate targets to demonstrate drug
activity. The primary objective of this study is to evaluate the
impact of 12 months treatment with ATH434 on brain iron by MRI
(QSM/R2*) in a more advanced patient population than is being
studied in Alterity’s randomized Phase 2 trial. Additional
information on the open label Phase 2 trial can be found at
clinicaltrials.gov NCT05864365.
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 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 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
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
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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