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 composition of matter patent previously allowed
by the United States Patent and Trademark Office (USPTO) has now
been granted. The patent, entitled “Compounds for and methods of
treating diseases” (No. 11,603,364), covers more than 100 novel
compounds with an acyl hydrazone (AH) structure and provides 20
years of exclusivity.
Alterity also announced a Licensing Agreement
for the new patent and a sub-licensing agreement for PBT2 to
Professor Colin Masters, M.D., A.O., to advance these compounds for
the treatment of Alzheimer’s and related diseases. Under the
license agreement, Alterity grants the entire rights to the AH
patent as well as an exclusive worldwide license to develop and
commercialize both AH and PBT2 in Alzheimer’s disease (AD). In
exchange, Alterity is entitled to future royalties of net sales
from the assets.
Professor Masters is a preeminent researcher in
the field of Alzheimer’s disease whose work characterizing the beta
amyloid protein (Aβ amyloid) that forms the cerebral plaques in AD
has laid the foundation for recently approved treatments for this
neurodegenerative disease. He has received numerous awards and
recognition for his research, including the Order of Australia
(A.O.) which recognizes Australians who have demonstrated
exceptional achievement, and a Lifetime Achievement Award in
Alzheimer's Disease Research from the Alzheimer's Association.
“This new patent is a testament to the ongoing
success of our discovery team as they continue to generate novel
small molecules with potential to treat important neurodegenerative
diseases,” said David Stamler, M.D., Chief Executive Officer,
Alterity. “We are excited to extend our long-standing collaboration
with Professor Masters, whose understanding of the role of beta
amyloid in Alzheimer’s disease pathogenesis and research cannot be
overstated. Because the AH compounds act similarly to PBT2, this
deal makes good sense for future research and development to occur
alongside one another. This arrangement broadens the opportunity
for both programs since our clinical development efforts are
currently focused on Parkinsonian disorders such as Multiple System
Atrophy and Parkinson’s disease.”
Professor Masters, added, “Our research teams
are excited for the opportunity to advance PBT2 and the compounds
associated with the AH patent. We look forward to continued
collaborations with Alterity as we look to add value to existing
patents and find ways to develop novel Alzheimer’s
disease-modifying therapeutics using the latest technologies
employing imaging and biofluid biomarkers.”
The acyl hydrazone patent is based on a new
scaffold that is distinct from those specified in recent patents
granted to Alterity and includes more than 100 novel small
molecules, at least one of which has demonstrated efficacy in an
animal model of dementia.
PBT2 is a low molecular weight drug candidate
discovered by Alterity and is currently the Company’s product
candidate for Alzheimer’s disease. It is orally bioavailable,
crosses the blood-brain barrier, and was found to be safe and well
tolerated in clinical trials in healthy volunteers and patients.
PBT2 has demonstrated efficacy in individuals with Alzheimer’s
disease.
About Alzheimer’s Disease
Alzheimer's disease is a progressive neurologic
disorder that causes the brain to shrink (atrophy) and brain cells
to die. Alzheimer's disease is the most common cause of dementia —
a continuous decline in thinking, behavioral, and social skills
that affects a person's ability to function independently.
Approximately 5.8 million people in the United States age 65 and
older live with Alzheimer's disease. Of those, 80% are 75 years old
and older. Out of the approximately 50 million people worldwide
with dementia, between 60% and 70% are estimated to have
Alzheimer's disease. Medications may temporarily improve or slow
progression of symptoms, but there is no treatment that cures
Alzheimer's disease or alters the disease process in the brain. In
advanced stages of the disease, complications from severe loss of
brain function, such as dehydration, malnutrition or infection,
result in death.1
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.
1Mayo Clinic: Alzheimer’s Disease
Authorisation & Additional informationThis
announcement was authorized by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
AustraliaAna Luiza
Harropwe-aualteritytherapeutics@we-worldwide.com+61 452 510 255
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,
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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