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 July 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:
July 26, 2023
2
Exhibit 99.1
Alterity Therapeutics Phase
2 Data Monitoring Committee Recommends
Continuing Clinical Trial as Planned
- ATH434-201 Trial on Track
to Complete Enrollment in Q3 2023 –
- Top-Line Data Expected by the
End of 2024 -
MELBOURNE, AUSTRALIA
AND SAN FRANCISCO, USA – 26 July 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 an independent Data Monitoring Committee (DMC) recommended the ATH434-201 Phase 2 study continue as
planned. The ATH434-201 clinical trial is a randomized, double-blind, placebo- controlled investigation of ATH434 in patients with
early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its
progression.
The DMC conducted a prespecified
review of unblinded clinical data from an initial cohort of study participants. The DMC expressed no concerns about safety and recommended
that the study continue without modification. The plan for the DMC to review initial safety data was cleared with the U.S. Food and Drug
Administration.
“The recommendation to continue
the Phase 2 trial as planned marks another significant advance in the development of ATH434 for this devastating condition,” said
David Stamler, M.D., Chief Executive Officer of Alterity. “Enrollment is continuing globally, and this milestone brings us one step
closer to creating a novel treatment for individuals with MSA. We remain on track to complete enrollment in the third quarter of this
year and look forward to top-line data by the end of next year.”
The ATH434-201 Phase 2 clinical trial
is evaluating 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. The selected biomarkers, including brain iron and
aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity.
Wearable sensors will also be employed to evaluate motor activities that are important to patients with MSA. The study is expected to
enroll approximately 60 adults 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 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 nerve cells 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 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
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. Alterity also has a broad drug discovery platform generating
patentable chemical compounds to intercede in disease processes. 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 authorised by David Stamler, CEO of Alterity
Therapeutics Limited.
1 | Multiple System Atrophy | National Institute of Neurological
Disorders and Stroke (nih.gov) |
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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