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 November 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:
November 27, 2023
2
Exhibit 99.1
Alterity Therapeutics Announces
Presentation of Novel Biomarker Data for Evaluation of Multiple System Atrophy
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA – 27 November 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 a poster presentation from the Company’s Biomarkers of progression in Multiple
System Atrophy (bioMUSE) Natural History Study at the recent 34th International Symposium on the Autonomic Nervous System
(AAS).
The poster entitled, “Relationship between N-acetylaspartate
and neurofilament light chain in multiple system atrophy” was presented by Paula Trujillo Diaz, PhD, Research Assistant Professor,
Department of Neurology, Vanderbilt University Medical Center. Because MSA is pathologically characterized by degeneration and loss of
neurons in the brain, identifying biomarkers to assess disease severity is critical. N-acetylaspartate (NAA) is a novel biomarker of neuronal
integrity with potential for assessing disease severity, monitoring the course of disease, and evaluating the efficacy of disease modifying
therapies in MSA. In the study, the data provided evidence that NAA correlates with levels of neurofilament light chain (NfL) in patients
with early MSA. NfL is a widely used biomarker that is a measure of neuronal damage. The results suggest that NAA concentration may reflect
the degree of neuronal integrity in these subjects.
“These valuable data produced
by our partners at Vanderbilt continue to demonstrate that we are leading the way in the biomarker evaluation of MSA,” said David
Stamler, M.D., Chief Executive Officer of Alterity. “The data presented at AAS reveals another potentially important biomarker for
the evaluation of this rapidly progressive disease with no approved treatment. The field is seeking non-invasive biomarkers to assess
disease severity and this novel biomarker represents another potential shot on goal for demonstrating the efficacy of ATH434, our lead
drug candidate in Phase 2 for the treatment of MSA. The findings suggest that the NAA metabolite may be a useful biomarker for assessing
disease severity and treatment response in MSA.”
The study assessed 13 early-stage MSA patients
(motor symptom onset ≤ 4 yrs) with diagnosis supported by a multimodal approach that utilizes neuroimaging and fluid
biomarkers1. Participants completed neurologic examination and clinical assessment with the Unified Multiple System
Atrophy Rating Scale (UMSARS) and the Natural History and Neuroprotection in Parkinson Plus Syndromes scale (NNIPPS). All
participants had α-synuclein seed amplification assay results consistent with MSA, CSF NfL > 2000, and plasma NfL > 20.
The investigators utilized a non-invasive MRI technique known as magnetic resonance spectroscopy (MRS) that allows quantification of
metabolites such as NAA in the brain. NAA is a marker of neuronal integrity given its role in cellular energetics and myelin
synthesis. In this study, the investigators tested the hypothesis that the quantity of NAA measured using MRS is correlated with NfL
levels.
A copy of the poster is available at https://alteritytherapeutics.com/the-science/
..
| 1 | Claasen, et al, “A multimodal approach for diagnosis of
early Multiple System Atrophy”, MDS 2023 |
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 bioMUSE
Biomarkers of progression in Multiple
System Atrophy (bioMUSE) is a natural history study that aims to track the progression of individuals with MSA, a parkinsonian disorder
without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under the
direction of Daniel Claassen, M.D., M.S., Professor of Neurology and Principal Investigator. Natural history studies are important for
characterizing disease progression in selected patient populations. The study has provided rich data for optimizing the design of Alterity’s
randomized ATH434-201 Phase 2 clinical trial and enrolled approximately 20 individuals with clinically probable or clinically established
MSA. BioMUSE continues to provide vital information on early stage MSA patients, informs the selection of biomarkers suitable to evaluate
target engagement and preliminary efficacy, and delivers clinical data to characterize disease progression in a patient population that
mirrors those currently enrolling in the Phase 2 clinical trial.
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.2
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.
| 2 | Multiple System Atrophy | National Institute of Neurological
Disorders and Stroke (nih.gov) |
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.
3
Alterity Therapeutics (PK) (USOTC:PRNAF)
과거 데이터 주식 차트
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Alterity Therapeutics (PK) (USOTC:PRNAF)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024