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) diseases, today reported a relevant new peer-reviewed
publication in the journal Science Translational Medicine, titled
"Widespread cell stress and mitochondrial dysfunction occur in
patients with early Alzheimer's disease."1
ANAVEX®2-73 activates the sigma-1 receptor
(SIGMAR1). Data suggest that activation of SIGMAR1 results in the
restoration of homeostatic function within the body and is pivotal
to restoring neural cell balance and promoting
In this publication, position emission
tomography (PET) and magnetic resonance imaging (MRI) markers were
utilized to show that impaired mitochondrial oxidative
phosphorylation and synaptic loss are central to neurodegeneration
in the cellular pathology of Alzheimer's disease (AD).
One of the featured observations was an increase
in SIGMAR1 expression in the early stages of AD. Increased SIGMAR1
expression may be an endogenous, compensatory mechanism for the
loss of other receptors and proteostasis.3 However, PET scans of
patients with more advanced AD diagnoses show a reduction of
The publication is consistent with previous
scientific findings that AD is a multifactorial disease, where
several pathways interlink and cause cognitive impairments.5
Currently available drugs tend to target only a single pathway and
mitigate the symptoms of AD without slowing the disease
progression. Combinatorial therapy has been suggested as a
treatment strategy; however, the existence of drug-drug interaction
is a concern. Hence, there is a need to develop drug molecules that
can target multiple pathways to halt disease progression and
improve memory function.
SIGMAR1 has emerged as one of the prominent
targets in treating neurodegeneration. It is involved in modulating
glutamate levels, maintaining endoplasmic reticulum (ER) function,
and regulating calcium. SIGMAR1 activation promotes neurogenesis,
reduces reactive oxygen species (ROS) formation, suppresses
neuroinflammation, and ameliorates Aβ toxicity.6 SIGMAR1 also
promotes autophagy and results in the degradation of amyloid-beta
precursor protein (APP), thereby normalizing Aβ production.7
Recent studies with ANAVEX®2-73 and ANAVEX®3-71
show that SIGMAR1 activation also involves mitochondrial
performance, an intricate phenomenon that provides energy for
cellular functions.8 SIGMAR1 agonists, including ANAVEX®2-73 and
ANAVEX®3-71, have been reported to reduce toxic Aβ, tau, and
"This independent paper provides further
evidence of the relevance of sigma-1 receptor activation as a
compensatory mechanism to chronic CNS diseases, which is currently
being tested in a late-stage placebo-controlled ANAVEX®2-73 Phase
2b/3 clinical Alzheimer's disease study with expected read-out this
fall 2022," said Christopher U Missling, PhD, President and Chief
Executive Officer of Anavex.
Anavex Life Sciences' precision medicine
platform includes small molecule drug lead candidate ANAVEX®2-73
for the treatment of Alzheimer's disease, Parkinson's disease, and
Rett syndrome and ANAVEX®3-71 for schizophrenia, frontotemporal
dementia, and Alzheimer's disease.
Economic Burden of Alzheimer's Disease10
Alzheimer's disease is the most common cause of
dementia and the fifth leading cause of death in adults older than
65 years. The estimated total healthcare costs for the treatment of
Alzheimer's disease in 2020 were estimated at $305 billion, with
the cost expected to increase to more than $1 trillion as the
population ages. Most of the direct costs of care for Alzheimer's
disease are attributed to skilled nursing care, home healthcare,
and hospice care. Indirect costs of care, including quality of life
and informal caregiving, are likely underestimated and are
associated with significant negative societal and personal
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.
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
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free: 1-844-689-3939Email:
Tel: 516-662-9461Email: firstname.lastname@example.org
1 Venkataraman, A. V., Mansur, A., Rizzo, G., Bishop, C., Lewis,
Y., Kocagoncu, E., Lingford-Hughes, A., Huiban, M., Passchier, J.,
Rowe, J. B., Tsukada, H., Brooks, D. J., Martarello, L., Comley, R.
A., Chen, L., Schwarz, A. J., Hargreaves, R., Gunn, R. N., Rabiner,
E. A., & Matthews, P. M. (2022). Widespread cell stress and
mitochondrial dysfunction occur in patients with early Alzheimer's
disease. Science translational medicine, 14(658), eabk1051.
https://doi.org/10.1126/scitranslmed.abk1051.2 Advances in
Experimental Medicine and Biology Volume 964 (2017) Sigma
Receptors: Their Role in Disease and as Therapeutic Targets.3
Brimson JM, Brimson S, Chomchoei C, et al. Using Sigma-ligands as
part of a multireceptor approach to target diseases of the brain.
Expert opinion on therapeutic targets. 2020; Wallace DR, Mactutus
CF, Booze RM. Sigma binding sites identified by [3H] DTG are
elevated in aged Fischer_344Å~ Brown Norway (F1) rats. Synapse.
2000;35(4):311-313.4 Mishina M, Ohyama M, Ishii K, et al. Low
density of sigma 1 receptors in early Alzheimer’s disease. Annals
of nuclear medicine. 2008;22(3):151-151.5 Prasanth MI, Malar DS,
Tencomnao T, Brimson JM. The emerging role of the sigma-1 receptor
in autophagy: Hand-in-hand targets for the treatment of
Alzheimer's. Expert Opin Ther Targets. 2021 Jun 10. doi:
10.1080/14728222.2021.1939681.6 Nguyen L, Lucke-Wold BP, Mookerjee
SA, et al. Role of sigma-1 receptors in neurodegenerative diseases.
Journal of pharmacological sciences. 2015;127(1):17-29; Moriguchi
S, Shinoda Y, Yamamoto Y, et al. Stimulation of the sigma-1
receptor by DHEA enhances synaptic efficacy and neurogenesis in the
hippocampal dentate gyrus of olfactory bulbectomized mice. PloS
one. 2013;8(4):e60863-e60863; Rosen DA, Seki SM,
Fernández-Castañeda A, et al. Modulation of the sigma-1
receptor–IRE1 pathway is beneficial in preclinical models of
inflammation and sepsis. Science Translational Medicine.
2019;11(478):eaau5266; Maurice T, Volle J-N, Strehaiano M, et al.
Neuroprotection in non-transgenic and transgenic mouse models of
Alzheimer's disease by positive modulation of σ1 receptors.
Pharmacological research. 2019;144:315-330.7 Jaeger PA, Pickford F,
Sun C-H, et al. Regulation of amyloid precursor protein processing
by the Beclin 1 complex. PloS one. 2010;5(6):e11102.8 Goguadze, N.,
Zhuravliova, E., Morin, D., Mikeladze, D., & Maurice, T.
(2019). Sigma-1 Receptor Agonists Induce Oxidative Stress in
Mitochondria and Enhance Complex I Activity in Physiological
Condition but Protect Against Pathological Oxidative Stress.
Neurotoxicity research, 35(1), 1–18.9 Lahmy V, Meunier J, Malmström
S, et al. Blockade of Tau hyperphosphorylation and Aβ 1–42
generation by the aminotetrahydrofuran derivative ANAVEX2-73, a
mixed muscarinic and σ 1 receptor agonist, in a nontransgenic mouse
model of Alzheimer’s disease. Neuropsychopharmacology.
2013;38(9):1706-1706; Fisher A, Bezprozvanny I, Wu L, Ryskamp DA,
Bar-Ner N, Natan N, Brandeis R, Elkon H, Nahum V, Gershonov E,
LaFerla FM, Medeiros R. AF710B, a Novel M1/σ1 Agonist with
Therapeutic Efficacy in Animal Models of Alzheimer’s Disease.
Neurodegener Dis. 2016;16(1-2):95-110.10 W Wong Economic Burden of
Alzheimer Disease and Managed Care Considerations Am J Manag Care.
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