MELBOURNE, Australia
and SAN FRANCISCO, June 23, 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 that the Italian Medicines Agency,
or Agenzia Italiana del Farmaco (AIFA), has authorized
Alterity to conduct its Phase 2 clinical trial of ATH434 in
Multiple System Atrophy (MSA), a rare and highly debilitating
Parkinsonian disorder.
"Approval by the Italian authorities provides another
endorsement of the approach we are taking with our Phase 2 clinical
trial," said David Stamler, M.D.,
Chief Executive Officer, Alterity. "MSA is a devastating disease,
and we want to reach patients in several regions of the globe to
offer ATH434 as a potential treatment for their condition. With our
trial now open for enrolment in New
Zealand and regulatory authorizations in the UK and
Italy, we are focused on opening
study sites in these regions and expanding access to other
countries throughout the year."
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 imaging and protein biomarkers, such as aggregating
α-synuclein and excess iron, which are important contributors to
MSA pathology. Clinical and biomarker endpoints, including use of
wearable sensors, 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 doses 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 has successfully completed a
Phase 1 clinical trial demonstrating the agent is well tolerated,
orally bioavailable, and achieved brain levels comparable to
efficacious levels in animal models of MSA, with the objective of
restoring function in patients with MSA and other Parkinsonian
disorders.
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.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of section 27A of the Securities Act of 1933 and
section 21E of the Securities Exchange
Act of 1934. The Company
has tried to identify such forward-looking statements by use
of such words as "expects," "intends," "hopes," "anticipates,"
"believes," "could," "may," "evidences" and "estimates," and other
similar expressions, but these words are not the exclusive means of
identifying such statements.
Important factors that could cause
actual results to differ materially from those indicated
by such forward-looking statements
are described in the sections
titled "Risk Factors"
in the Company's filings with the SEC, including its most recent
Annual Report
on Form 20-F as well as reports on Form 6-K, including, but not limited
to the following: statements relating
to the Company's drug development program, including, but
not limited to the initiation, progress and outcomes of clinical
trials of the Company's drug development program,
including, but not limited to, ATH434, and any other statements that are not historical
facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the
difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company's
drug components, including, but not limited
to, ATH434, uncertainties relating to the impact of the
novel coronavirus (COVID-19) pandemic
on the company's business, operations and employees,
the ability of the Company to procure
additional future sources of financing, unexpected
adverse side effects or inadequate therapeutic efficacy of the
Company's drug compounds, including, but not
limited to, ATH434, that could slow or
prevent products coming to market, the
uncertainty of obtaining patent
protection for the Company's
intellectual property or trade secrets, the
uncertainty of successfully enforcing the Company's patent rights
and the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press
release is based only on information currently available to us and
speaks only as of the date on which it is made. We undertake no obligation to publicly update
any forward-looking statement,
whether written or oral, that may be made from time to time, whether as a result
of new information, future developments or
otherwise.
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SOURCE Alterity Therapeutics