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 presentations from its bioMUSE natural history study
of Multiple System Atrophy (MSA) were delivered at the
International Congress of Parkinson’s Disease and Movement
Disorders (MDS) taking place August 27 - 31, 2023 in Copenhagen,
Denmark.
The posters presented from Alterity’s bioMUSE
study address the need for incorporating biomarkers as a critical
component for diagnosis of MSA. The diagnosis of early MSA can be
challenging as individuals often present similarly to Parkinson’s
disease (PD). In contrast to PD, MSA is rapidly progressive and,
therefore, it is vital to accurately diagnose patients enrolling in
clinical trials.
“The approach of using a diverse set of
biomarkers to augment clinical criteria for MSA will greatly
improve the diagnosis of this devastating disease,” said David
Stamler, M.D., Chief Executive Officer of Alterity. “Based on our
collaboration with the clinical and neuroimaging experts from
Vanderbilt, we are in a unique position to implement this strategy
in our ATH434-201 Phase 2 clinical trial. Our unique protocol
design is helping ensure we are enrolling the right patient
population thus giving ATH434 the best chance at
success.”
Daniel O. Claassen, M.D., M.S., Professor of
Neurology, Vanderbilt University Medical Center, added, “As with
any disease, accurate diagnosis is critical to provide the best
treatment options for patients, and because MSA is a rare, rapidly
progressing disease, timing is of the essence. Diagnosis of
early-stage MSA is vital for maximizing neuronal preservation with
disease modifying therapies, and thus identifying biomarkers for
early pathology is critical. Our findings presented this week
support the use of specialized MRI techniques and fluid biomarkers
to improve the specificity of MSA diagnosis as well as assess
clinical measures of disease severity and treatment response in
MSA.”
Two poster presentations were given at the MDS
Congress.
The poster entitled, “A multimodal approach for
diagnosis of early Multiple System Atrophy” was presented by Dr.
Claassen. The analysis describes three clinically probable MSA
patients with divergent MRI and fluid biomarker data, supporting
the use of biomarkers to improve diagnostic accuracy in early MSA.
The presented cases demonstrate that no single biomarker can be
relied upon to aid in the diagnosis of early MSA. In addition,
divergent clinical and biomarker findings in this case series
suggests a multimodal clinical-biomarker approach is required for
accurate diagnosis of clinically probable or early MSA. These
examples support application of clinical and quantitative
biomarkers in clinical trials evaluating disease-modifying
treatments for early MSA.
The poster entitled, “Preliminary evidence for
evolution of myoinositol and N-acetylaspartate as biomarkers of
disease severity in early-stage Multiple System Atrophy” was
presented by Paula Trujillo Diaz, PhD, Research Assistant
Professor, Department of Neurology, Vanderbilt University Medical
Center. The study assessed 13 early-stage MSA patients (motor
symptoms ≤ 3 yrs) with diagnosis based on clinical parameters,
fluid biomarkers, and quantitative MRI for iron deposition. The
investigators then applied a non-invasive MRI technique known as
magnetic resonance spectroscopy (MRS) that allows metabolite
quantification in the brain, including myoinositol (mI; a marker of
gliosis) and N-acetylaspartate (NAA; a marker of neuronal
integrity). The results suggest that an increase in mI/water and
decrease in NAA/water decrease over one-year in patients with MSA
is consistent with MSA pathology. The findings suggest that
metabolite concentration by MRS may be useful biomarkers for
assessing clinical measures of disease severity and treatment
response in MSA.
The poster presentations can be accessed on the
Published Scientific Research section of the Alterity website
here.
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
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
1Multiple System Atrophy | National Institute of Neurological
Disorders and Stroke (nih.gov)
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.
Investor and Media Contacts:
AustraliaHannah
Howlettwe-aualteritytherapeutics@we-worldwide.com+61 450 648
064
U.S.Remy Bernardaremy.bernarda@iradvisory.com
+1 (415) 203-6386
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