Alterity Therapeutics Enrolls First Patient in Italy in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy
08 March 2023 - 11:25PM
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 first participant in Italy has been dosed in the
Company’s Phase 2 clinical trial of ATH434 in Multiple System
Atrophy (MSA), a rare and highly debilitating Parkinsonian
disorder.
“We are pleased to announce that our first
participant in Europe has been dosed in our Phase 2 clinical trial
as we look to bring a potential new treatment option to individuals
living with MSA,” said David Stamler, M.D., Chief Executive
Officer, Alterity. “We are grateful to our clinical colleagues in
Italy who enrolled quickly following approval of the study. We
continue to make excellent progress advancing the trial in several
countries globally.”
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
1Multiple System Atrophy | National Institute of Neurological
Disorders and Stroke (nih.gov)
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:
Australia
Ana Luiza Harrop
we-aualteritytherapeutics@we-worldwide.com
+61 452 510 255
U.S.
Remy Bernarda
remy.bernarda@iradvisory.com
+1 (415) 203-6386
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