U.S. now open for enrollment of rare,
rapidly progressive Parkinsonian Disorder
MELBOURNE, Australia and SAN FRANCISCO, Jan. 9, 2023
/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 the Company's Phase 2 clinical trial
of ATH434 for the treatment of patients with Multiple System
Atrophy (MSA) is now open for enrollment at Vanderbilt University Medical Center in
Nashville, Tennessee.
"Vanderbilt University has been a
tremendous partner for our ATH434 clinical development program, and
we are very excited to utilize their expertise as our first U.S.
trial site," said David Stamler,
M.D., Chief Executive Officer, Alterity. "ATH434 is a potential
disease modifying treatment for individuals living with MSA, a
rapidly progressive Parkinsonian disorder with no approved
treatment. The opening of enrollment in the U.S. is a major
milestone for this trial and we are now actively recruiting
patients in three regions: Europe,
Asia-Pacific, and the U.S. We
expect to add additional sites in the U.S. and Europe over the next few months to increase
access to the study."
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 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 has been granted
Orphan designation for the treatment of MSA by the U.S. FDA and the
European Commission.
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
1National 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/alterity-therapeutics-launches-ath434-phase-2-clinical-trial-in-the-united-states-for-the-treatment-of-individuals-with-multiple-system-atrophy-301716116.html
SOURCE Alterity Therapeutics