Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the
Company”), a biotechnology company dedicated to developing disease
modifying treatments for neurodegenerative diseases, today issued a
letter to shareholders.
Dear Shareholders:
As we begin a new year, I wanted to take a
moment to thank you for your support of Alterity, reflect on our
accomplishments in 2023, and lay out our key milestones for 2024.
We remain steadfastly committed to developing new treatments for
individuals living with neurodegenerative diseases.
2023 was a critical year for us and I am
pleased to report that we hit all of our intended
milestones.
We have an extremely robust program evaluating
neurodegenerative diseases with a current focus on Multiple System
Atrophy, or MSA, a disease related to Parkinson’s. As a reminder,
MSA is a rare and aggressive Parkinsonian disorder that rapidly
progresses and causes profound disability. Although similar to
Parkinson’s disease, affected individuals cannot adequately
maintain their blood pressure or control bowel and bladder function
– areas that drastically impair quality of life. The pathological
hallmark of MSA is accumulation of the protein alpha-synuclein and
neuron loss in multiple brain regions within the central nervous
system. While some of the symptoms of MSA can be treated with
available medications, currently there are no drugs that can slow
disease progression and there is no cure.
We are looking to change the paradigm of
treating MSA with our lead clinical development candidate ATH434,
an orally administered agent discovered in house to target
neurodegeneration. ATH434 acts by redistributing excess
iron in the brain, reducing the protein α-synuclein, and rescuing
neuronal function. Based on accumulated pre-clinical data and an
understanding of how MSA develops and progresses, we believe ATH434
has excellent potential to treat MSA as well as Parkinson’s
disease. Importantly, ATH434 has been granted Orphan Drug
Designation (ODD) for the treatment of MSA by the U.S. FDA and the
European Commission. ODD comes with many benefits including 7-10
years of market exclusivity, tax credits and fee reductions, as
well as protocol assistance from each agency.
Our primary Phase 2 clinical trial is a
randomized, double-blind placebo-controlled study (ATH434-201)
evaluating ATH434 in individuals with early-stage MSA. I am very
proud of our 201 study team for fulfilling our goals in 2023 by
opening numerous clinical trial sites around the world and
completing enrollment of all study participants in November 2023.
The ATH434-201 study is treating these participants for 12
months and, therefore, the study will complete in November
2024. Once this portion of the trial is completed, we will
then analyze the data and report topline results in January
2025.
In addition, during 2023 we also initiated a
second, Phase 2 clinical trial (ATH434-202) in individuals with
more advanced MSA than in the 201 trial. A key aim of the 202 study
is to assess the efficacy of ATH434 on objective biomarkers that
measure target engagement and are relevant to the underlying
pathology of MSA. While the 202 trial is also treating participants
for 12-months, it has an open label design that will allow us to
perform interim analyses of biomarker data while the study is
ongoing, giving us a potential early indication of efficacy.
We expect to report preliminary six-month data from the
initial patients enrolled in the ATH434-202 trial in the first half
of this year.
Our bioMUSE Natural
History study also continues to generate invaluable data related to
the understanding of MSA and its early presentation. The
insights gained from this study enabled us to refine the design of
our ongoing Phase 2 studies, optimizing patient selection and
analysis of key endpoints. Along with our academic partners at
Vanderbilt University Medical Center in the U.S., we have delivered
several data presentations at important neurology conferences
during 2023. Important elements of the data included an enhanced
understanding of MSA, new methods to diagnose and potentially treat
the disease, and potential novel biomarkers for evaluating disease
modifying treatments such as ATH434. We expect to report additional
data from bioMUSE this year as well.
In December 2023, we presented promising new
data on the effect of ATH434 in a Parkinson’s disease primate
model. Personally, I am very excited about these findings 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.
As I have laid out above, 2024 will be a
pivotal year for us. The primate data in Parkinson’s
disease has improved our ability to predict clinical outcomes and
increases our overall confidence level in our ongoing Phase 2
clinical trials in MSA. We are currently running two trials
allowing us to study MSA populations of differing severity. Our
ATH434-201 clinical trial will complete in November with topline
data reported shortly thereafter. We will also be able to report
preliminary data from our ATH434-202 trial in the first half of
this year. And, we expect to make additional progress with bioMUSE
and the advancement of ATH434 in Parkinson’s disease.
Thank you for your continued interest and
support and we look forward to keeping you updated on our
progress.
David Stamler, M.D., Chief Executive Officer of
Alterity
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
informationThis announcement was authorized by David
Stamler, CEO of Alterity Therapeutics Limited.
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.
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
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