- First patient dosed in Phase 2 clinical trial for ATH434 in
New Zealand, trial opens in
Europe and Australia
- Approval of Investigational New Drug application by FDA to
bring the Phase 2 clinical trial to the
United States
- Data from bioMUSE study provides a quantitative measurement of
MSA progression
- Cash balance on 30 September 2022
of A$31.9M
MELBOURNE, Australia and SAN
FRANCISCO , Oct. 28, 2022 /PRNewswire/ -- Alterity
Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the
Company"), a biotechnology company dedicated to developing disease
modifying treatments for neurodegenerative diseases, releases its
Appendix 4C Quarterly Cash Flow Report and update on company
activities for the quarter ending 30th September 2022 (Q1 FY23).
The Company's cash position on 30
September 2022 was $31.9M with
operating cash outflows of $4.8M, an
increase on previous quarters due to the commencement of Alterity's
Phase 2 clinical trial for lead drug candidate ATH434 for the
treatment of Multiple System Atrophy (MSA), a rare Parkinsonian
disorder with no approved therapy.
Chief Executive Officer David
Stamler, M.D., said: "We are excited by the tremendous
progress we made to advance our Phase 2 clinical trial over the
last several months. We achieved a major milestone by dosing our
first patient and the trial is now running in multiple countries.
MSA is a devastating disease that currently has no cure, and our
team is dedicated to supporting our research partners around the
world as they recruit, screen, and enrol patients into the study,
pursuing our goal of validating our treatment."
In accordance with ASX Listing Rule 4.7C, payments made to
related parties and their associates included in item 6.1 of the
Appendix 4C incorporates directors' fees, consulting fees,
remuneration and superannuation at commercial rates.
Operational Activities
Alterity achieved significant milestones during the first
quarter of 2023.
The first patient was dosed in New
Zealand in the Company's Phase 2 clinical trial assessing
ATH434 as a potentially disease modifying treatment for individuals
with early-stage MSA. In addition, the first site in Europe was opened for enrolment in the
United Kingdom. Subsequent to the
closing of the quarter, Alterity also announced the opening of
enrolment for the trial in Australia. Management continues to prioritise
the expansion of the Phase 2 clinical trial into these and other
countries.
In September 2022, the Company
received approval of its Investigational New Drug (IND) application
by the U.S. Food and Drug Administration (FDA) to allow the
evaluation of ATH434 in individuals with MSA in the United States. This follows receipt of
approval from the Italian Medicines Agency, or Agenzia Italiana del
Farmaco (AIFA) to expand recruitment and clinical sites into
Italy.
The randomized, double-blind, placebo-controlled study will
enrol approximately 60 adult patients who will receive two dose
levels of ATH434 or placebo over a period of 12 months. Results
will provide an opportunity to detect changes in efficacy endpoints
to optimize design of a definitive Phase 3 study.
Multiple data presentations were given in September and October
from Alterity's bioMUSE Natural History Study that continue to
inform the Phase 2 trial. At the International Congress of
Parkinson's Disease and Movement Disorders, the poster, entitled
"Wearable Sensors for Quantitative Motor Assessments in Multiple
System Atrophy", correlated data from wearable sensors with
clinical assessments of motor function. The study determined that
wearable sensors provide a quantitative assessment of MSA
progression that is not captured by neurological examination. At
the American Neurological Association Annual Meeting, the poster,
entitled "Deep Learning Segmentation Improves Precision of
Volume Assessment of Subcortical Structures in early MSA,"
identified a method for measuring brain volume in MSA patients with
improved precision, a finding that will increase the chance of
demonstrating efficacy on biomarkers in Phase 2.
Corporate activity
Alterity continues to raise awareness on its work in
neurodegenerative diseases through media and investor engagement
opportunities. Dr David Stamler
presented at Switzer's Small & Micro Cap Virtual Conference and
Alterity was featured in the Stockhead Investor Guide: Health &
Biotech FY2023.
The Company also continues to support the MSA community and
partnered with The Multiple System Atrophy Coalition to support the
2022 Patient & Family Conference in September.
In this quarter, Alterity received an extension of 180 calendar
days until February 23, 2023 to
regain compliance with Nasdaq's minimum bid price requirement. As
previously reported, in February 2022
the Company received a deficiency letter from the Listing
Qualifications Department of Nasdaq notifying that the bid price
for the Company's American Depositary Shares ("ADSs") had closed
below the minimum $US1.00 per share
requirement for continued inclusion on the Nasdaq Global Market.
Alterity continues to work towards regaining compliance with
Nasdaq.
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 forms of
atypical Parkinsonism such as Multiple System Atrophy (MSA). ATH434
has 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 has been granted
Orphan designation for the treatment of MSA by the U.S. FDA and the
European Commission. ATH434 is currently in a randomized,
double-blind, placebo-controlled Phase 2 clinical trial of ATH434
in patients with early-stage MSA.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare, neurodegenerative
disease characterized by a combination of symptoms that affect both
the autonomic nervous system and 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 motor impairment, 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 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.
Authorization & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics
Limited.
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SOURCE Alterity Therapeutics