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 30 September 2023 (Q1
FY24).
“Alterity had a great start to the 2024
financial year with significant developments in the first quarter,”
said David Stamler, M.D., Chief Executive Officer of Alterity. “Our
two Phase 2 clinical trials in Multiple System Atrophy (MSA) are on
track as we look to develop a new treatment for this devastating
rare disease. Of note, we have closed screening in the ATH434-201
study and expect to close enrollment imminently. In addition, an
independent Data Monitoring Committee (DMC) recommended that the
trial continue as planned and they expressed no concerns about
safety. These events are important milestones in the development of
ATH434 for the treatment of early-stage MSA.”
“While the ATH434-201 trial is evaluating
individuals with early-stage MSA, we are also conducting a second
Phase 2 trial in individuals with more advanced disease. This open
label, biomarker study will give us the opportunity to assess the
effect of ATH434 in multiple populations and we also expect it to
provide preliminary data in the first cohort of participants in the
first half of next year,” concluded Dr. Stamler.
The Company’s cash position on 30 September 2023
was A$16.7M with operating cash outflows for the quarter of A$4.1M,
offset by a refund of $4.7M from the Australian Taxation Office
under the Australian Government’s Research and Development Tax
Incentive (R&DTI) Scheme for eligible activities conducted
during the financial year ending 30 June 2022.
Operational Activities
ATH434–201: Randomized, Double-Blind Phase 2
Clinical Trial in MSA
Today, Alterity announced that screening has
closed for its ATH434-201 Phase 2 clinical trial, an important step
to completing enrollment in the study. On 26 July, Alterity
announced that an independent DMC recommended the trial continue as
planned. The DMC conducted a prespecified review of unblinded
clinical data from an initial cohort of study participants. The DMC
expressed no concerns about safety and recommended that the study
continue without modification.
This randomized, double blind, placebo
controlled clinical trial continues to progress with early-stage
MSA participants enrolled in seven countries globally. The trial
has been well received by the study investigators as they implement
Alterity’s state of the art methods to diagnose, treat and track
the disease.
ATH434–202: Open-label, Biomarker Phase 2
Clinical Trial in MSA
The ATH434-202 trial is enrolling according to
plan. The study is assessing the effect of ATH434 treatment on
neuroimaging and protein biomarkers to evaluate target engagement,
in addition to clinical measures, safety, and pharmacokinetics. The
primary objective of this study is to evaluate the impact of 12
months treatment with ATH434 on brain iron by MRI in a more
advanced patient population than is being studied in Alterity’s
double blind Phase 2 trial. Preliminary data from the first cohort
in this study is expected in the first half of 2024.
bioMUSE Natural History Study
Alterity’s bioMUSE natural history study
continues to produce meaningful data to address the need for novel
approaches to the evaluation of individuals with MSA. The diagnosis
of early MSA can be challenging as individuals often present
similarly to Parkinson’s disease. On 31 August, presentations from
bioMUSE were delivered at the prominent International Congress of
Parkinson’s Disease and Movement Disorders (MDS). The presentations
addressed the importance of incorporating biomarkers in diagnosis
of MSA and support the need for a timely and accurate diagnosis to
ensure that the right treatment can be delivered to patients.
Findings from the bioMUSE study are being
incorporated into the Company’s Phase 2 studies. Alterity’s unique
protocol designs help to ensure they are enrolling the right
patient population with confirmed MSA, thus giving ATH434 the best
chance at success. Based on the collaboration with clinical and
neuroimaging experts from Vanderbilt University Medical Center in
the U.S., Alterity is in a unique position to implement this
strategy in its development programs.
Composition of Matter Patent Granted in
Europe
The European Patent Office granted Alterity a
new composition of matter patent. The patent secures broad
protection over a new class of iron chaperone drug candidates for
treating major neurodegenerative diseases. It is well established
that excess iron in the brain is implicated in the pathology of
many important neurodegenerative diseases, including Alzheimer’s
and Parkinson’s diseasesi.
The composition of matter patent, entitled,
“Compounds for and Methods of Treating Diseases”, Patent No.
3938364 covers more than 150 novel pharmaceutical compositions that
are designed to redistribute the excess iron implicated in
neurodegenerative diseases. The patent will confer on Alterity 20
years of exclusivity over the compounds claimed in the patent, thus
providing a strong basis for drug development and
commercialization.
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 authorised by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
AustraliaHannah
Howlettwe-aualteritytherapeutics@we-worldwide.com+61 4 5064
8064
U.S.Remy Bernardaremy.bernarda@iradvisory.com
+1 (415) 203-6386
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,
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.
_______________
i Dusek, P. et al. Cerebral Iron Deposition in
Neurodegeneration. Biomolecules 2022, 12, 714.
https://doi.org/10.3390/biom12050714.
Alterity Therapeutics (NASDAQ:ATHE)
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