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 promising wearable sensor data from the Biomarkers
of Progression in Multiple System Atrophy (bioMUSE) natural history
study was presented at the American Academy of Neurology Annual
Meeting.
The poster, entitled, Wearable Sensors for
Quantitative Motor Assessments in Multiple System Atrophy, was
presented by Daniel Claassen, MD, Professor of Neurology at
Vanderbilt University Medical Center, and Principal Investigator in
the bioMUSE study. The analysis was conducted to determine the
utility of quantitative wearable sensors in 17 participants with
early stage (less than three years of motor symptoms) multiple
system atrophy (MSA).
“This analysis from bioMUSE demonstrates that
wearable sensors can quantify motor impairment in MSA patients that
is not captured by neurological examination,” said David Stamler,
M.D., Chief Executive Officer, Alterity. “MSA is a devastating
condition and use of novel measures to assess disease progression
and inform future clinical trials is a win for the entire
community. As a result of this natural history study, we have
incorporated wearable sensor data into our Phase 2 clinical trial
for ATH434 as one of our secondary endpoints to determine the
effect of our agent on gait stability. We look forward to
additional data from bioMUSE as we strive to better understand the
trajectory of MSA and utilize our findings in future clinical
trials.”
In the study, a strong relationship was evident
between sensor parameters and motor assessments. Specifically,
sensor parameters correlated strongly with clinical scales of motor
impairment and may be useful in assessing disease progression.
Importantly, an assessment known as the Timed Up and Go strongly
correlated with several gait parameters, including bouts of
walking, minutes walking, minutes of standing, and minutes of
lying. Because the Timed Up and Go reliably quantifies functional
mobility in a clinic setting, the new data suggesting the clinical
relevance of these outcomes is important in assessing MSA in the
outpatient setting. The results from bioMUSE will inform future
trials in MSA as potential outcome measures for disease modifying
therapies.
Alterity’s medical meeting presentations can be
accessed on the Company’s website on The Science page.
About
bioMUSE
Biomarkers of progression in Multiple System
Atrophy (bioMUSE) is an ongoing, 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 U.S.
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 has provided rich data for
optimizing the design of Alterity’s Phase 2 clinical trial and will
be expanded to include a total of 20 patients with MSA. The ongoing
study will continue to provide vital information on early stage MSA
patients, inform the selection of biomarkers suitable to evaluate
target engagement and preliminary efficacy, and deliver clinical
data to characterize disease progression in a patient population
that mirrors those to be enrolled 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
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 a randomized, double-blind,
placebo-controlled Phase 2 clinical trial in patients with
early-stage MSA. ATH434 has been granted Orphan designation for the
treatment of MSA by the U.S. FDA and the European Commission.
About ATH434
Phase 2 Clinical
Trial
The Phase 2 clinical trial is a randomized,
double-blind, placebo-controlled investigation of ATH434 in
patients with early-stage MSA. The study will evaluate 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 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
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 Bernarda
remy.bernarda@iradvisory.com+1 (415) 203-6386
Forward
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