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 promising new data on the effect of ATH434 in a
Parkinson’s disease primate model was presented at the Future of
Parkinson’s Disease Conference 2023 that took place November 30 –
December 3, 2023 in Austin, TX, USA.
The poster, entitled, “Effects of ATH434, a
Clinical-Phase Small Molecule with Moderate Affinity for Iron, in
Hemiparkinsonian Macaques”, was presented by Margaret Bradbury,
PhD, Vice President of Research and Nonclinical Development at
Alterity and collaborators from Vanderbilt University Medical
Center and the Florey Institute of Neuroscience in Melbourne. The
presentation demonstrated that ATH434 treatment improved motor
performance and general function in monkeys with experimentally
induced Parkinson’s disease. The favorable impact on Parkinson’s
symptoms was associated with lower iron levels in the area of
pathology. In addition, ATH434 treatment increased levels of
synaptophysin, a protein marker that reflects functional
connections between neurons.
David Stamler, M.D., Chief Executive Officer of
Alterity, commented, “These new data are exciting because we have
shown for the first time that ATH434 can reduce Parkinson’s
symptoms in a higher order animal – the monkey. Importantly, the
improvements in motor skills and general functioning that parallel
human parkinsonism were associated with reductions in iron in
affected brain regions, validating the approach we are using in our
ongoing clinical trials. The data from this study improve our
ability to predict clinical outcomes and increases our confidence
level in our ongoing Phase 2 clinical trials in Multiple System
Atrophy, a parkinsonian disorder with similar underlying pathology
to Parkinson’s disease.”
The study compared daily oral doses of ATH434 (3
or 10 mg/kg) versus a vehicle (placebo) for 12-14 weeks after
parkinsonian symptoms were evident. Monkeys were assessed with the
Parkinson Behavior Rating Scale (PBRS) before, during and after
dosing. At Week 12, all evaluable ATH434-treated monkeys (n=5) had
stable or improving PBRS scores from Baseline to Week 12 whereas
two of three vehicle-treated monkeys did not demonstrate
improvement or worsened, as expected from the progressive nature of
the Parkinson model. The components of the PBRS scale indicate that
ATH434 reduced motor impairment and improved general functions such
as posture, balance, activity, and gait. Favorable parkinsonian
outcomes observed in each of the ATH434-treated monkeys were
associated with lower iron in the right substantia nigra. In
addition, monkeys with improved scores had higher right dorsal
striatal synaptophysin, indicating functional recovery of nerve
endings in this critical motor pathway.
The poster presentation can be accessed on the
Published Scientific Research section of the Alterity website
here.
Webcast details
AUSTRALIA PARTICIPANTS: |
|
Date: |
Wednesday, 6
December 2023 |
|
Time: |
9:00 a.m. AEDT (Sydney/Melbourne) |
UNITED STATES PARTICIPANTS: |
|
Date: |
Tuesday, 5
December 2023 |
|
Time: |
2:00 p.m. Pacific Time |
|
|
5:00 p.m. Eastern Time |
Register for the Zoom
webcast:https://us02web.zoom.us/webinar/register/WN_9Lv1OWMtSSSqdJrRsKRiTA#/registrationRegistration
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registration.
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 Parkinson’s Disease
Parkinson's disease (PD) is the second most
common neurodegenerative disorder and causes unintended or
uncontrollable movements of the body along with neuropsychiatric
and other nonmotor features. The precise cause of PD is
unknown, but some cases are hereditary while others are thought to
occur from a combination of genetics and environmental factors that
trigger the disease. In PD, brain cells become damaged or die
in the substantia nigra, the part of the brain that produces
dopamine--a chemical needed to produce smooth, purposeful movement.
The cardinal symptoms of PD are tremors, rigidity, slowing of
movements, and later in disease, impaired balance. Other symptoms
may include difficulty swallowing, chewing, or speaking; emotional
changes; urinary problems or constipation; dementia or other
cognitive problems; fatigue; and problems sleeping.1
Nearly one million people in the U.S. and more than 10 million
people worldwide are living with PD. Approximately 60,000 Americans
are diagnosed with PD each year.2
1National Institute of Health: Neurological
Disorders and Stroke, Parkinson's Disease Information Page;
2Parkinson’s Foundation
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 and is currently being evaluated in two Phase 2 clinical
trials in Multiple System Atrophy. Alterity also has a broad drug
discovery platform generating patentable chemical compounds to
treat the underlying pathology of neurological diseases. 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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