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 February 2024
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.
|
Alterity Therapeutics Limited |
|
|
|
By: |
/s/ Geoffrey P. Kempler |
|
|
Geoffrey P. Kempler |
|
|
Chairman |
Date:
February 20, 2024
2
Exhibit 99.1
Alterity Therapeutics to Present
New Data at the Upcoming American Academy of Neurology 2024 Annual Meeting
– Positive Efficacy Data for ATH434 in a Primate Model of Parkinson’s Disease to be Presented at International Conference –
– Baseline Biomarker Data to be Presented from Ongoing ATH434-201 Phase 2 Clinical Trial –
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA – 20 February 2024: 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 three
posters from the Company’s development pipeline will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting
taking place April 13-18, 2024, in Denver, Colorado, USA.
“We are thrilled to be presenting
at this prestigious international neurology conference, including new baseline biomarker data on ATH434 from our ongoing Phase 2 randomized,
double blind clinical trial in multiple system atrophy (MSA), as well as compelling preclinical primate data on ATH434 in Parkinson’s
disease,” said, David Stamler, M.D., Chief Executive Officer of Alterity. “In addition, we remain in the vanguard of biomarker
evaluation of MSA, as our partners at Vanderbilt University will present important data from our bioMUSE natural history study. AAN promises
to be a very productive conference for us as we advance our MSA program toward data later this year and expand our development toward
Parkinson’s disease.”
| Title: | A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein
Aggregation, for the Treatment of Multiple System Atrophy (MSA) |
| Lead Author: | David Stamler, M.D., Chief Executive Officer of Alterity
Therapeutics |
| Date/Time: | Sunday, April 14, from 11:45 a.m. 12:45 p.m. Mountain Time (U.S.) |
| Title: | Neurofilament Light Chain and Clinical Progression in Early
Multiple System Atrophy |
| Lead Author: | Daniel O. Claassen, M.D., M.S., Professor of Neurology,
Vanderbilt University Medical Center |
| Date/Time: | Monday, April 15, from 5:30 p.m. to 6:30 p.m. Mountain Time
(U.S.) |
| Title: | Effects of ATH434, a Clinical-phase Small Molecule with Moderate
Affinity for Iron, in a Parkinson’s Disease Model in Macaques |
| Lead Author: | Margaret Bradbury, Vice President, Research and Nonclinical
Development, Alterity Therapeutics |
| Date/Time: | Tuesday, April 16, from 11:45 a.m. to 12:45 p.m. Mountain Time
(U.S.) |
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 ATH434-201 Phase 2 Clinical
Trial
The ATH434-201 Phase 2 clinical trial
is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the
effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate
efficacy, in addition to assessments of safety and pharmacokinetics. Selected biomarkers, such as brain iron and aggregating α-synuclein,
are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors have
also been employed to evaluate motor activities that are important to patients with MSA. The study enrolled 77 adults who were randomly
assigned to receive one of two dose levels of ATH434 or placebo. Participants will receive treatment for 12 months which will provide
an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the
Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.
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.1
| 1 | Multiple System Atrophy | National Institute of Neurological
Disorders and Stroke (nih.gov) |
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.3 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.4
| 1 | Beauchamp et al, “ATH434 Rescues Pre-motor
Hyposmia in a Mouse Model of Parkinsonism, Neurotherapeutics, DOI:10.1007/s13311-022-01300-0 |
| 3 | National Institute of Health: Neurological Disorders and Stroke,
Parkinson’s Disease Information Page; |
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.
4
Alterity Therapeutics (PK) (USOTC:PRNAF)
Historical Stock Chart
From May 2024 to Jun 2024
Alterity Therapeutics (PK) (USOTC:PRNAF)
Historical Stock Chart
From Jun 2023 to Jun 2024