MELBOURNE,
Australia and SAN
FRANCISCO, Oct. 26,
2020 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH,
NASDAQ: ATHE) ("Alterity" or "the Company") today announced it has
commenced enrolling patients with Multiple System Atrophy (MSA) in
its bioMUSE Study in the United
States.
BioMUSE is a natural history study that aims to track the
progression of patients with MSA, a Parkinsonian disorder without
approved therapy. The study is being conducted in collaboration
with Vanderbilt University Medical
Center in the US under the direction of Daniel Claassen, MD, Associate Professor of
Neurology and Principal Investigator. Natural history studies are
important for characterizing disease progression in selected
patient populations. The study will provide vital information on
early stage MSA patients to optimize the design of Alterity's Phase
2 study in MSA. The study will also inform the selection of
biomarkers suitable to evaluate target engagement and
preliminary efficacy.
Alterity's lead compound ATH434 has already successfully completed Phase 1 clinical trial and is advancing
toward a Phase 2 clinical trial.
Dr. Claassen said: "This is an important study to expand our
understanding of MSA. We are enrolling early stage patients who
stand to gain the most from disease modifying treatments. I look
forward to working with Alterity on this project and I hope it can
provide the foundation for advancing treatments such as ATH434 into
the clinic."
MSA is a neurodegenerative disease with major sources of
disability resulting from motor symptoms characteristic of
Parkinson's disease and impaired ability to maintain normal blood
pressure, bowel
function and bladder control. Current treatment includes medications and lifestyle changes to help manage
symptoms, but there is no treatment of the underlying cause and
no cure.
The study is enrolling early stage MSA patients and will track
changes in clinical measures and biomarkers for up to one year.
Over the course of the study, patients will undergo comprehensive
evaluation with detailed neurological examination and clinical
rating scales of motor, autonomic and activities-of-daily- living
symptoms along with specialized neuroimaging and assessment of
protein biomarkers in diverse biological specimens.
Data from bioMUSE will also be used to inform patient selection in Alterity's upcoming Phase 2 clinical trial
of ATH434, its lead clinical candidate for the treatment of MSA.
The US FDA has encouraged Alterity to
utilize data from the bioMUSE study to
aid in the development of efficacy endpoints
for the Phase 2 study.
Vanderbilt University Medical Centre
is one of the largest academic medical centres in the southeast US
managing more than 2 million patients each year. The School of
Medicine's biomedical research program is among the nation's top 10
in terms of National Institutes of Health peer review funding.
Dr David Stamler, Chief Medical
Officer, added: "As we prepare for our Phase 2 study, the data from
bioMUSE will provide key information to help us optimize the study
design. Starting this study brings us one step closer to finding
novel treatments for this devastating condition."
END
Authorization & Additional information
This announcement was authorized by Geoffrey Kempler, Chairman and 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 web site at
www.alteritytherapeutics.com.
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
and death.
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 updated 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