NEW
YORK, Feb. 9, 2021
/PRNewswire/ -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE)
("Alterity" or "the Company") has today announced the award of a
grant from The Michael J. Fox Foundation for Parkinson's Research
to determine optimal dosing of its lead drug candidate ATH434 for
Parkinson's disease (PD) based on imaging of brain iron.
The funding for US$495,000 will be
used to evaluate the pharmacologic profile of ATH434 in a primate
model to determine the optimal dose of ATH434 in future Parkinson's
disease clinical trials. This is the second grant that
Alterity has received from The Michael J. Fox Foundation to support
the development of ATH434 in PD.
Alterity Chief Executive Officer Dr David Stamler said, "The Michael J. Fox
Foundation is an incredible organisation at the frontier of
research and treatment innovation for Parkinson's disease, which
remains incurable and affects an estimated 7-10 million people
worldwide[i]."
"ATH434 targets alpha-synuclein misfolding and aggregation
through the redistribution of excess labile iron, and our first
indication Multiple System Atrophy (MSA) is on track to start its
phase 2 clinical trial later this year. The potential to expand
into other Parkinsonian disorders that implicate alpha-synuclein
has always been part of our strategy and this funding allows us to
take another step towards realizing a program in Parkinson's
disease."
Parkinson's disease (PD) is the second most common age-related
neurodegenerative disorder after Alzheimer's disease and occurs
when brain cells that make dopamine, a chemical that underlies
control of movement, degenerate and ultimately die. Because
Parkinson's disease can cause tremor, slowness, stiffness, and
problems with balance and walking, it is called a "movement
disorder." But non-motor symptoms such as constipation, depression,
and impaired memory can also be part of PD. It is a lifelong and
progressive disease, which means that symptoms slowly worsen over
time.[ii]
While available therapies can treat some symptoms, people with
Parkinson's urgently need new treatments to slow or stop disease
progression and improve quality of life.
Dr Werner Poewe, Professor of
Neurology at the Medical University Innsbruck, Austria, said, "By targeting alpha-synuclein,
ATH434 has potential to modify the course of synucleinopathies such
as Parkinson's disease and MSA.
"Aggregates of misfolded alpha-synuclein protein are widely
distributed in the brains of individuals affected by these
disorders, and by reducing their build-up ATH434 has potential to
improve the motor and non-motor symptoms of these devastating
conditions. I look forward to seeing the results from the dose
optimization studies for PD clinical trials and future development
in this indication."
The project will be led by Margaret
Bradbury, PhD, Vice President, Nonclinical Development, in
collaboration with Daniel Claassen,
MD, Associate Professor of Neurology at Vanderbilt University Medical Center and
David Finkelstein, PhD, who heads
the PD Research Laboratory at the Florey Institute of Neuroscience
and Mental Health.
The Michael J. Fox Foundation is dedicated to finding a cure for
Parkinson's disease through an aggressively funded research agenda
and to ensuring the development of improved therapies for those
living with Parkinson's today.
Authorization & Additional information
This
announcement was authorized by David
Stamler, CEO of Alterity Therapeutics Limited.
About Alterity Therapeutics Limited and ATH434
Alterity's lead candidate, ATH434 (formerly PBT434), is the
first of a new generation of small molecules designed to inhibit
the aggregation of pathological proteins implicated in
neurodegeneration. ATH434 has been shown to reduce abnormal
accumulation of α-synuclein and tau proteins in animal models of
disease by redistributing labile iron in the brain. In this way, it
has potential to treat Parkinson's disease and atypical forms of
Parkinsonism such as Multiple System Atrophy (MSA) and Progressive
Supranuclear Palsy (PSP).
ATH434 has been granted Orphan designation for the treatment of
MSA by the US FDA and the European Commission.
For further information please visit the Company's website at
www.alteritytherapeutics.com.
[i] Ref:
Parkinson's Disease Statistics -
Parkinson's News Today
[ii] Ref: Parkinson's 101 | Parkinson's Disease
(michaeljfox.org)
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare and rapidly progressive
neurological disorder affecting adults. It has no known cause. In
addition to presenting with motor symptoms like those in
Parkinson's disease, individuals with MSA may also experience loss
of ability to coordinate voluntary movements and impaired
regulation of involuntary body functions such as blood pressure,
bowel and bladder control. Most of these symptoms are not addressed
by available drugs for patients with Parkinson's disease. As the
condition progresses, daily activities become increasingly
difficult and complications such as increased difficulty
swallowing, vocal cord paralysis, progressive immobility, and poor
balance become more prominent. Symptoms tend to appear after age 50
and rapidly advance, leading to profound disability.
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
(formerly PBT434), 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, uncertainties relating to
the impact of the novel coronavirus (COVID-19) pandemic on the
company's business, operations and employees, 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 patent protection for the Company's intellectual property
or trade secrets, including, but not limited to, the intellectual
property relating to ATH434.
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.
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SOURCE Alterity Therapeutics Limited