Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company developing
differentiated therapeutics for the treatment of neurodegenerative
and neurodevelopmental disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) disorders, today announced that United States Patent and
Trademark Office (USPTO) issued U.S. Patent No. 11,446,275 to
Anavex, with claims to treatment methods using its leading drug
candidate, ANAVEX®2-73 (blarcamesine) and its analogs, for
ameliorating biochemical and functional abnormalities associated
with methyl-CpG binding protein 2 defects (MeCP2 defects).
Such defects encompass a range of
neurodevelopmental and neurological disorders, including but not
limited to, Rett syndrome, Angelman syndrome, Williams syndrome,
cerebral palsy, autism spectrum disorder, and multiple
sclerosis.
Anavex’s newest patent is the latest in a series
of patents recently granted to Anavex and is expected to remain in
force at least until 2037, not including any patent term
extensions. Recent US patent grants to Anavex also include U.S.
Patent No. 10,426,754 granted to Anavex in October 2019, U.S.
Patent No. 10,507,196 granted to Anavex in December 2019, and U.S.
Patent No. 10,888,543 granted to Anavex in January 2021. The new
‘275 patent adds to the comprehensive patent portfolio supporting
ANAVEX®2-73 (blarcamesine), and its analogs, such as ANAVEX®1-41
and ANAVEX®19-144, which are all orally available sigma-1 receptor
(SIGMAR1) agonists. The ‘275 patent covers the therapeutic use of
these compounds, including ANAVEX®2-73 (blarcamesine), in oral,
transdermal, and parenteral compositions to treat abnormalities
associated with methyl-CpG binding protein 2 defects (MeCP2
defects).
Using precision medicine included SIGMAR1
biomarker of response, ANAVEX®2-73 (blarcamesine) successfully
completed a Phase 2 in adult Rett syndrome and a Phase 3 in adult
Rett syndrome, respectively. In addition, ANAVEX®2-73
(blarcamesine) successfully completed a Phase 2 in Parkinson’s
disease dementia, Phase 2a clinical trial for Alzheimer’s disease
and is expected a larger Phase 2b/3 study for Alzheimer’s disease
(NCT03790709) reading out in the fall of 2022.
"We are pleased with the continued development
of the patent portfolio for ANAVEX®2-73 (blarcamesine). This latest
patent will fortify our robust patent portfolio relating to
ANAVEX®2-73 (blarcamesine),” said Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. “Along with other
allowances, it demonstrates our strong overall commitment to
protecting the innovation and commercial opportunity of our entire
product portfolio," said Christopher U. Missling, PhD, President
and Chief Executive Officer of Anavex.
ANAVEX®2-73 (blarcamesine) is an orally
available, small-molecule activator of the sigma-1 receptor, which,
data suggest, is pivotal to restoring neural cell homeostasis and
promoting neuroplasticity.1
About and Rett Syndrome and Neurodevelopmental
Disorders
Rett syndrome is a devastating, non-inherited
genetic post-natal progressive neurodevelopmental disorder that
occurs almost exclusively in girls and leads to severe impairments,
affecting nearly every aspect of the child’s life: their ability to
speak, walk, eat, and control some autonomic functions (e.g.,
peripheral vasomotor, breathing). The hallmark of Rett syndrome is
near constant repetitive hand movements while awake. The disease is
characterized by normal early growth and development (6 to 18
months) followed by a slowing of development, loss of purposeful
use of the hands and spoken language, repetitive hand movements,
gait impairments, autistic features, and, in a high proportion of
individuals, seizures and behavioral abnormalities. Although there
could be partial recovery of loss functions, most affected
individuals showed marked communication and motor impairments and
are diagnosed with intellectual disability.
Rett syndrome is caused by mutations in the
MECP2 gene and strikes all racial and ethnic groups. The disease
occurs worldwide in approximately one in every 10,000 to 15,000
live births. There is currently no cure for Rett syndrome. MECP2
mutations have been also associated with other clinical
presentations, including autism spectrum disorder, Angelman-like
syndrome, attention-deficit–hyperactivity disorder, nonspecific
intellectual disability, bipolar disorder, schizophrenia, and in
males severe postnatal encephalopathy. Abnormal MeCP2 expression
has also been reported in the brain of individuals with autism
spectrum disorder. While rare, health care costs associated with
these conditions are long term and can be devastating.
About Multiple Sclerosis and Neurological
Disorders
Neurological disorders are diseases of the
peripheral and central nervous system (CNS). They include disorders
of the brain, spinal cord, cranial nerves, peripheral nerves, nerve
roots, autonomic nervous system, neuromuscular junction, and
muscle. Multiple sclerosis (MS) is a type of neurological disorder,
specifically a chronic inflammatory-neurodegenerative disease of
the central nervous system (CNS), resulting in the accumulation of
irreversible disabilities such as muscle weakness, visual
disturbances, and other neurological impairments. MS is the most
common autoimmune disorder of the CNS, and worldwide, ~2.3 million
people are affected. Most people experience their first symptoms of
MS between the ages of 20 and 40. Currently there is no cure for MS
and many medications have serious side effects and some carry
significant risks. A huge unmet need remains for agents directly
interacting with the central nervous system to achieve
regeneration, axonal protection, neuronal protection and
remyelination.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of novel therapeutics for the treatment of
neurodegenerative and neurodevelopmental disorders, including
Alzheimer's disease, Parkinson's disease, Rett syndrome, and other
central nervous system (CNS) diseases, pain, and various types of
cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine),
has successfully completed a Phase 2a clinical trial for
Alzheimer's disease, a Phase 2 proof-of-concept study in
Parkinson's disease dementia, and both a Phase 2 and a Phase 3
study in adult patients with Rett syndrome. ANAVEX®2-73 is an
orally available drug candidate that restores cellular homeostasis
by targeting sigma-1 and muscarinic receptors. Preclinical studies
demonstrated its potential to halt and/or reverse the course of
Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant,
anti-amnesic, neuroprotective, and anti-depressant properties in
animal models, indicating its potential to treat additional CNS
disorders, including epilepsy. The Michael J. Fox Foundation for
Parkinson's Research previously awarded Anavex a research grant,
which fully funded a preclinical study to develop ANAVEX®2-73 for
the treatment of Parkinson's disease. ANAVEX®3-71, which targets
sigma-1 and M1 muscarinic receptors, is a promising clinical stage
drug candidate demonstrating disease-modifying activity against the
major hallmarks of Alzheimer's disease in transgenic (3xTg-AD)
mice, including cognitive deficits, amyloid, and tau pathologies.
In preclinical trials, ANAVEX®3-71 has shown beneficial effects on
mitochondrial dysfunction and neuroinflammation. Further
information is available at www.anavex.com. You can also connect
with the company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not
strictly historical in nature are forward-looking statements. These
statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties.
Actual events or results may differ materially from those projected
in any of such statements due to various factors, including the
risks set forth in the Company’s most recent Annual Report on Form
10-K filed with the SEC. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. All forward-looking statements are qualified in
their entirety by this cautionary statement and Anavex Life
Sciences Corp. undertakes no obligation to revise or update this
press release to reflect events or circumstances after the date
hereof.
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
info@anavex.com
Investors:Andrew J.
BarwickiInvestor RelationsTel: 516-662-9461Email:
andrew@barwicki.com
1 Advances in Experimental Medicine and Biology Volume 964
(2017) Sigma Receptors: Their Role in Disease and as Therapeutic
Targets.
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