Alterity Therapeutics Receives Regulatory Authorization in France and Austria to Proceed with ATH434 Phase 2 Clinical Trial
17 February 2023 - 08:44AM
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 the Company has been granted authorization to
conduct its Phase 2 clinical trial for ATH434 in Multiple System
Atrophy (MSA) by the Austrian Federal Office for Safety in
Healthcare and the French National Agency for the Safety of
Medicine and Health Products. MSA is a rare and highly debilitating
Parkinsonian disorder.
“The regulatory approvals in France and Austria
will allow us to expand our footprint in Europe and are another
important step forward for our ATH434 development program,” said
David Stamler, M.D., Chief Executive Officer, Alterity. “With the
trial now open in five countries we are focused on providing access
to our Phase 2 clinical trial for individuals living with MSA. We
expect to open trial sites in France and Austria over the next few
months.”
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 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 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
informationThis announcement was authorized by David
Stamler, CEO of Alterity Therapeutics Limited.
Investor and Media Contacts:
AustraliaAna Luiza
Harropwe-aualteritytherapeutics@we-worldwide.com+61 452 510 255
U.S.Remy Bernardaremy.bernarda@iradvisory.com
+1 (415) 203-6386
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