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 August 2023
Alterity
Therapeutics Limited
(Name
of Registrant)
Level
3, 460 Bourke Street, Melbourne, VIC 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. 333-251647,
333-249311, 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.
|
Alterity Therapeutics Limited |
|
|
|
/s/ Geoffrey P. Kempler |
|
By: |
Geoffrey P. Kempler |
|
|
Chairman |
Date:
August 30, 2023
2
Exhibit 99.1
Alterity Therapeutics Presents
New Data on Multiple System Atrophy, a Rare Parkinsonian Disorder
- Presentations Convey Novel Approach for Improving
Diagnostic Accuracy and Tracking Disease Severity in MSA -
-
Data Presented at the International Congress of Parkinson’s Disease and Movement Disorders -
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA – 31 August 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 presentations
from its bioMUSE natural history study of Multiple System Atrophy (MSA) were delivered at the International Congress of Parkinson’s
Disease and Movement Disorders (MDS) taking place August 27 - 31, 2023 in Copenhagen, Denmark.
The posters presented from Alterity’s
bioMUSE study address the need for incorporating biomarkers as a critical component for diagnosis of MSA. The diagnosis of early MSA can
be challenging as individuals often present similarly to Parkinson’s disease (PD). In contrast to PD, MSA is rapidly progressive
and, therefore, it is vital to accurately diagnose patients enrolling in clinical trials.
“The approach of using a diverse
set of biomarkers to augment clinical criteria for MSA will greatly improve the diagnosis of this devastating disease,” said David
Stamler, M.D., Chief Executive Officer of Alterity. “Based on our collaboration with the clinical and neuroimaging experts from
Vanderbilt, we are in a unique position to implement this strategy in our ATH434-201 Phase 2 clinical trial. Our unique protocol design
is helping ensure we are enrolling the right patient population thus giving ATH434 the best chance at success.”
Daniel O. Claassen, M.D., M.S., Professor
of Neurology, Vanderbilt University Medical Center, added, “As with any disease, accurate diagnosis is critical to provide the best
treatment options for patients, and because MSA is a rare, rapidly progressing disease, timing is of the essence. Diagnosis of early-stage
MSA is vital for maximizing neuronal preservation with disease modifying therapies, and thus identifying biomarkers for early pathology
is critical. Our findings presented this week support the use of specialized MRI techniques and fluid biomarkers to improve the specificity
of MSA diagnosis as well as assess clinical measures of disease severity and treatment response in MSA.”
Two poster presentations were given at
the MDS Congress.
The
poster entitled, “A multimodal approach for diagnosis of early Multiple System Atrophy” was presented by Dr. Claassen.
The analysis describes three clinically probable MSA patients with divergent MRI and fluid biomarker data, supporting the use of
biomarkers to improve diagnostic accuracy in early MSA. The presented cases demonstrate that no single biomarker can be relied upon
to aid in the diagnosis of early MSA. In addition, divergent clinical and biomarker findings in this case series suggests a
multimodal clinical-biomarker approach is required for accurate diagnosis of clinically probable or early MSA. These examples
support application of clinical and quantitative biomarkers in clinical trials evaluating disease-modifying treatments for early
MSA.
The poster entitled, “Preliminary
evidence for evolution of myoinositol and N-acetylaspartate as biomarkers of disease severity in early-stage Multiple System Atrophy”
was presented by Paula Trujillo Diaz, PhD, Research Assistant Professor, Department of Neurology, Vanderbilt University Medical Center.
The study assessed 13 early-stage MSA patients (motor symptoms ≤ 3 yrs) with diagnosis based on clinical parameters, fluid biomarkers,
and quantitative MRI for iron deposition. The investigators then applied a non-invasive MRI technique known as magnetic resonance spectroscopy
(MRS) that allows metabolite quantification in the brain, including myoinositol (mI; a marker of gliosis) and N-acetylaspartate (NAA;
a marker of neuronal integrity). The results suggest that an increase in mI/water and decrease in NAA/water decrease over one- year in
patients with MSA is consistent with MSA pathology. The findings suggest that metabolite concentration by MRS may be useful biomarkers
for assessing clinical measures of disease severity and treatment response In MSA.
The poster presentations can be accessed
on the Published Scientific Research section of the Alterity website here.
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 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
1 | Multiple 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 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.
3
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