MELBOURNE, Australia, April 27,
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 United
Kingdom Medicines & Healthcare products Regulatory Agency
(MHRA) has accepted Alterity's clinical trial authorisation (CTA)
request to conduct its Phase 2 clinical trial for ATH434 in
Multiple System Atrophy (MSA), a rare and highly debilitating
Parkinsonian disorder.
"Approval by the MHRA in the UK is another important step
forward for our ATH434 clinical development program," said
David Stamler, M.D., Chief Executive
Officer, Alterity. "We expect to open our first Phase 2 clinical
trial site in New Zealand this
quarter and then expand the trial globally in the UK, other
European countries, Australia and
the United States. We look forward
to bringing this potential therapy to individuals with MSA who
currently have no treatments to address the underlying pathology of
their disease."
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 endpoints and other biomarkers will permit
comprehensive assessment of ATH434 efficacy along with
characterization of safety and pharmacokinetics. 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.
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]
[1]National 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/alterity-therapeutics-announces-regulatory-authorization-to-proceed-with-ath434-phase-2-clinical-trial-in-the-united-kingdom-301534019.html
SOURCE Alterity Therapeutics Limited