Highlights:
- Expanded participation in ATH434 Phase 2 clinical trial with
sites opened for recruitment in Australia, the
United States, and Italy
- Presented compelling bioMUSE data at two prestigious industry
conferences
- Granted a 20-year patent for 100 new compounds targeting
Parkinson's and Alzheimer's disease
- Cash balance on 31 December 2022
of A$25.3M
MELBOURNE, Australia and SAN FRANCISCO, Jan. 31,
2023 /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 31st December
2022 (Q2 FY23).
In this quarter, Alterity continued to focus its efforts on
running and expanding the Phase 2 clinical trial (the "Trial" or
"Study") for its lead drug candidate ATH434 in Multiple System
Atrophy (MSA), now enrolling patients across the globe. The
Company's cash position on 31 December
2022 was A$25.3M with
operating cash outflows of A$5.2M.
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.
David Stamler, M.D., Chief
Executive Officer, Alterity, commented, "We are excited about
the progress of our Phase 2 clinical trial which is now actively
recruiting participants with early-stage MSA in three regions
globally. We remain committed to bringing our potential disease
modifying therapy to individuals living with this devastating
condition. During the quarter, we also presented key bioMUSE data,
grew our intellectual property portfolio, and published preclinical
data giving us the opportunity to expand our pipeline into other
neurodegenerative diseases."
Operational Activities
ATH434 Phase 2 Clinical Trial
During the second quarter of FY23, Alterity launched in its
Phase 2 clinical trial of ATH434 in Sydney, Australia after successfully securing
ethics approval from the Human Research Ethics Committee (HREC) at
St. Vincent's Hospital, Melbourne.
After the quarter closed, in January
2023, the Company also announced further expansion of the
trial with sites now open form enrollment in the United States and Italy. With these additions, the Company is
now actively enrolling patients for the Study in three regions
(Europe, Asia-Pacific, and North America), and five countries
(New Zealand, Australia, United
Kingdom, U.S., and Italy).
Alterity's clinical team is providing ongoing support to the
investigators at each site working toward the goal of recruiting 60
patients globally.
bioMUSE (Biomarkers of progression in Multiple System
Atrophy)
The bioMUSE Natural History study continues to deliver valuable
data to de-risk Alterity's Phase 2 trial by providing insight into
the diagnosis and biomarkers of MSA to characterize disease
progression.
In October, and in conjunction with collaborators at
Vanderbilt University Medical Center,
the Company gave a poster presentation at the 147th Annual Meeting
of the American Neurological Association (ANA) on different methods
of measuring the volume of brain structures affected in individuals
with MSA, Parkinson's disease, and healthy controls. The poster,
Deep Learning Segmentation Improves Precision of Volume
Assessment of Subcortical Structures in early MSA, found
meaningful differences in the accuracy of three different
techniques for measuring the volume of subcortical brain structures
on MRI scans of patients with MSA and Parkinson's disease.
The Deep Learning method provides the basis for measuring brain
iron with high precision in the Phase 2 study.
In November, Alterity also presented data from bioMUSE at the
American Autonomic Society (AAS) 2022 Annual Conference. This
poster, entitled Urinary Symptom Profile in Early Multiple
System Atrophy, evaluated early stage MSA patients urinary
symptoms with the Urinary Symptom Profile (USP). The study results
indicate that the USP can be used for comprehensive evaluation of
urinary complaints, a symptom which can have a profound negative
impact on quality of life, in a group of patients similar to those
being studied in the Phase 2 trial.
Publication
In October 2022, a preclinical
investigation of ATH434 was published in the journal
Neurotherapeutics and demonstrated efficacy in an
animal model of Parkinson's disease. The publication, entitled,
"ATH434 Rescues Pre–motor Hyposmia in a Mouse Model of
Parkinsonism" assessed the impact of ATH434 on motor and non-motor
manifestations in experimentally induced Parkinson's disease. The
investigation showed that treatment with ATH434 prevented the
development of motor impairment, which was associated with a
reduction in iron levels and preservation of nerve cells in the
brain region affected in Parkinson's. This study adds to the weight
of evidence regarding ATH434 as a potential disease modifying
therapy for Parkinsonian disorders.
Intellectual Property
Strengthening its IP portfolio, Alterity secured a new
composition of matter patent from the United States Patent and
Trademark Office (USPTO) in December. The patent, entitled,
"Compounds for and methods of treating diseases", is based
on a new scaffold that includes more than 100 novel compounds, at
least one of which has demonstrated efficacy in an animal model of
dementia.
The new patent covers iron chaperones, small molecules capable
of binding and redistributing excess iron in the central nervous
system, implicated in the pathology of many important
neurodegenerative diseases, including Alzheimer's and Parkinson's
diseases. Alterity will have 20 years of exclusivity for these
compounds, expanding the company's intellectual property estate for
treating major neurodegenerative diseases.
Corporate
Subsequent to the end of the quarter on 24 January 2023, Alterity received formal
notification from The Nasdaq Stock Market LLC confirming that the
Company had regained compliance with the minimum bid price
requirement under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid
Price Rule"), which requires that the Company's American Depositary
Shares ("ADS") maintain a minimum bid price of at least
US$1.00 per ADS, and that the matter
is now closed.
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 authorised by David Stamler, CEO of Alterity Therapeutics
Limited.
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SOURCE Alterity Therapeutics Limited