- Wearable sensors strongly correlated with clinical scales
on motor impairment -
- bioMUSE Study Validates Use of Wearable Sensors for
Alterity's Ongoing Phase 2 Clinical Trial -
MELBOURNE, Australia and SAN FRANCISCO, Sept. 26,
2022 /PRNewswire/ -- Alterity Therapeutics (ASX: ATH,
NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology
company dedicated to developing disease modifying treatments for
neurodegenerative diseases, today announced a poster from the
ongoing Biomarkers of Progression in Multiple System Atrophy
(bioMUSE) natural history study was presented at the International
Congress of Parkinson's Disease and Movement Disorders. The
presentation correlates data from wearable sensors with clinical
assessments of motor function in individuals with Multiple
System Atrophy (MSA).
MSA is a rapidly progressive parkinsonian disorder that results
in slowed movements, lack of coordination and difficulty with
walking (gait) and balance that predisposes to falls. The poster,
entitled Wearable Sensors for Quantitative Motor Assessments in
Multiple System Atrophy, describes 12 participants from the
ongoing bioMUSE study who wore sensors for up to one year to
characterize their motor disability in an outpatient setting. In
the study, sensor parameters strongly correlated with clinical
scales of motor impairment that were largely driven by changes in
gait stability. Investigators concluded that step count and walking
time are sensitive measures of disease progression in early
MSA.
"In this study, we were able to determine that wearable sensors
provide a quantitative measurement of MSA progression that is not
captured by neurological examination," said Daniel Claassen, MD, Associate Professor of
Neurology at Vanderbilt University
Medical Center and Principal Investigator in the bioMUSE study.
"The level of detail captured by the wearable sensors clearly
showed a meaningful slowdown in activity, particularly in patients
with rapidly progressive disease. These results provide a tool for
physicians to assess the gait and activity levels of their
patients, and will inform future trials in MSA as potential outcome
measures for disease modifying therapies."
David Stamler, M.D., Chief
Executive Officer, Alterity, added, "We are very encouraged by
these findings as they validate the use of wearable sensors in our
ongoing ATH434 Phase 2 clinical trial in MSA. We are using these
sensors in study participants to evaluate motor performance in a
real-world setting. Progressive decline in motor function
represents an important source of disability in MSA so it is
important to have tools to measure it with precision. The data
presented demonstrate that we can quantify activity levels of
participants to support the outcome of the study."
The poster presentation includes data from n=12 participants who
wore a PAMSys device, a validated wearable sensor for continuous
monitoring of gait and activity parameters. PAMSys actigraphy
sensors were worn continuously for up to 12-months, allowing
assessment of gait parameters (step count, bouts of walking, steps
per bout, cadence/variability), postures (minutes of sitting,
lying, standing, or walking) and postural transitions
(sit-to-stand). Clinical assessments were obtained at baseline and
months 3, 6, 9 and 12. At each time point, sensor parameters were
obtained by averaging data over 14-day periods.
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 ATH434
Alterity's lead candidate, ATH434, 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 preclinically to reduce α-synuclein pathology and
preserve nerve cells by restoring normal iron balance in the brain.
In this way, it has excellent potential to treat Parkinson's
disease as well as various forms of atypical Parkinsonism such as
Multiple System Atrophy (MSA). ATH434 successfully completed Phase
1 studies demonstrating the agent is well tolerated, orally
bioavailable, and achieved brain levels comparable to efficacious
levels in animal models of 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 explore the effect of ATH434
treatment on neuroimaging and protein biomarkers, such as excess
brain iron and aggregating α-synuclein, which are important
contributors to MSA pathology. Clinical endpoints will permit
comprehensive assessment of ATH434 efficacy along with
characterization of safety and pharmacokinetics. The use of
wearable sensors will allow evaluation of motor parameters that are
important in patients with MSA. The study is expected to enroll
approximately 60 adult patients to receive one of two dose levels
of ATH434 or placebo. Patients 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 here:
ClinicalTrials.gov Identifier: NCT05109091.
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]
[1] National
Institute of Health: Neurological Disorders and Stroke, Multiple
System Atrophy Fact Sheet
|
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 information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics
Limited.
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