Second region now open for enrolment for rare, rapidly
progressive, neurodegenerative disease
MELBOURNE, Australia and
SAN FRANCISCO, Aug. 25, 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 the Company's Phase 2 clinical trial of ATH434 for the
treatment of patients with Multiple System Atrophy (MSA) is now
open for enrolment in the United Kingdom.
"Our Phase 2 clinical trial continues to progress as planned
with the launch of the study in the UK for patients with MSA," said
David Stamler, M.D., Chief Executive
Officer, Alterity. "In a short period of time we have now commenced
enrolment in our second region, and we look forward to broadening
our reach over the next several months. Because MSA is a rare
disease, we are committed to providing access to the trial to
eligible patients globally."
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 by
ClinicalTrials.gov Identifier: NCT05109091.
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 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.
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