SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-163
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For
the month of December 2023
Alterity
Therapeutics Limited
(Name
of Registrant)
Level 14, 350 Collins Street,
Melbourne, Victoria 3000 Australia
(Address
of Principal Executive Office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
This
Form 6-K is being incorporated by reference into our Registration Statement on Form S-8 (Files No. 333-251073, 333-248980
and 333-228671) and our
Registration Statements on Form F-3 (Files No. 333-274816, 333-251647, 333-231417
and 333-250076)
ALTERITY
THERAPEUTICS LIMITED
(a
development stage enterprise)
The
following exhibits are submitted:
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
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Alterity Therapeutics Limited |
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By: |
/s/ Geoffrey P. Kempler |
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Geoffrey P. Kempler |
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Chairman |
Date:
December 04, 2023
2
Exhibit 99.1
Alterity Therapeutics Reports Positive Efficacy
Data for ATH434 in a Primate Model of Parkinson’s Disease
- ATH434 improved motor performance and general
function –
- Webcast to be held this week to discuss new data
and recent clinical progress –
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA
– 4 December 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 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.3
Webcast details
AUSTRALIA PARTICIPANTS: |
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Date: |
Wednesday, 6 December 2023 |
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Time: |
9:00 a.m. AEDT (Sydney/Melbourne) |
UNITED STATES PARTICIPANTS: |
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Date: |
Tuesday, 5 December 2023 |
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Time: |
2:00 p.m. Pacific Time |
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5:00 p.m. Eastern Time |
Register for the Zoom webcast:
https://us02web.zoom.us/webinar/register/WN_9Lv1OWMtSSSqdJrRsKRiTA#/registration
Registration is required and dial in details will
be sent directly upon 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
3https://alteritytherapeutics.com/wp-content/uploads/Effects-of-ATH434_Dec02-2023.pdf
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 information
This announcement was authorized by David Stamler, CEO
of Alterity Therapeutics Limited.
Investor and Media Contacts:
Australia
Hannah Howlett
we-aualteritytherapeutics@we-worldwide.com
+61 450 648 064
U.S.
Remy Bernarda
remy.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.
5
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