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 announced long-lasting effect of clinical
drug candidate ANAVEX®3-71 in preventing cognitive decline in a
transgenic rat model of Alzheimer’s disease at the Alzheimer’s
Association International Conference (AAIC), taking place in San
Diego, CA and virtually on July 31 – August 4, 2022.
The poster presentation titled, “An M1/sigma-1
receptor agonist prevents cognitive deficits, reduces amyloid
plaques and neuroinflammation in a transgenic rat model of
Alzheimer’s amyloid pathology” is being presented by Chiara
Orciani, Sonia Do Carmo, Morgan K Foret, Helene Hall, Quentin
Bonomo, Agustina Lavagna, Chunwei Huang and A. Claudio Cuello from
McGill University, Montreal, Canada.
ANAVEX®3-71 (10 μg/kg) or control (saline) was
administered orally once daily in pre-plaque McGill-R-Thy1-APP
transgenic (Tg) rats (n=22) and wild-type (wt) rats (n=22) divided
into four groups, for seven months. Subsequently, after one month
of drug interruption, behavioral tests were performed: Novel Object
Recognition, Morris Water Maze, and Social Preference.
Biomarker analysis revealed that ANAVEX®3-71
prevents McGill-APP transgenic rats from increasing cortical (p ≤
0.05) and hippocampal (p ≤ 0.01) extracellular Aβ deposition.
ANAVEX®3-71 also significantly reduces microglia (p ≤ 0.05) and
astrocytes (p ≤ 0.05) recruitment towards Aβ-burdened neurons in
the hippocampus.
In the Novel Object Recognition behavioral test,
Tg control rats explored the novel object significantly less than
wt control rats (p ≤ 0.01). The impairment in Tg rats was
completely reversed with ANAVEX®3-71 (p ≤ 0.01).
In the Morris Water Maze behavioral test, the
rats showed significant differences in learning. Tg control rats
required more time to find the hidden platform than wt control rats
(p ≤ 0.01). Conversely, ANAVEX®3-71-treated Tg rats performed
significantly better than Tg control rats (p ≤ 0.05).
In the Social Preference behavioral test, Tg
control rats showed less interaction time with a “stranger rat”
than wt control rats (p ≤ 0.001). This deficit in Tg rats was
entirely reversed with ANAVEX®3-71 (p ≤ 0.0001).
This new data strengthens the importance and
applicability of Anavex’s Precision Medicine SIGMAR1 platform and
is consistent with previously reported therapeutic significant and
dose-dependent preclinical prevention of Aβ (Abeta) induced
biomarker-correlated cognitive impairments with ANAVEX®2-73.1
Both clinical drug candidates ANAVEX®2-73 and
ANAVEX®3-71 activate the sigma-1 receptor (SIGMAR1). Data suggests
that activation of SIGMAR1 results in the restoration of
homeostatic function within the body and is pivotal to restoring
neural cell balance and the promotion of neuroplasticity.2 Recent
independent findings strengthen the understanding of the beneficial
effects of SIGMAR1 activation as a compensatory mechanism to
chronic CNS diseases.3
“These results strengthen our SIGMAR1 product
platform and validate Anavex’s approach to CNS target selection and
drug discovery,” said Christopher U Missling, PhD, President and
Chief Executive Officer of Anavex. “This data increases Anavex’
confidence in the potential of our Precision Medicine technology to
address serious neurodegenerative diseases.”
The presentation of the Abstract #69100 is
available on the Anavex website (www.anavex.com).
About ANAVEX®3-71
ANAVEX®3-71, previously AF710B, represents
Anavex’s 2nd novel clinical sigma-1 and muscarinic receptor program
parallel to ANAVEX®2-73 (blarcamesine). Anavex is developing
ANAVEX®3-71 initially for the treatment of Frontotemporal Dementia
(FTD), for which ANAVEX®3-71 was previously granted orphan drug
designation by the FDA. ANAVEX®3-71 demonstrated disease-modifying
activity against the major hallmarks of Alzheimer’s disease in
transgenic (3xTg-AD) mice, including cognitive deficits, amyloid
and tau pathologies, as well as beneficial effects on mitochondrial
dysfunction and neuroinflammation.4 ANAVEX®3-71 recently completed
a placebo-controlled Phase 1 clinical trial (ANAVEX®3-71-001). The
study successfully reached primary and secondary safety
endpoints.5
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 muscarinic M1 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
https://www.anavex.com/post/anavex-life-sciences-announces-anavex-2-73-significantly-prevented-aβ-abeta-induced-deficits2
Advances in Experimental Medicine and Biology Volume 964 (2017)
Sigma Receptors: Their Role in Disease and as Therapeutic Targets.3
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. Epub ahead of print. PMID:
34110944.4 Fisher, A., Bezprozvanny, I., Wu, L., Ryskamp, D. A.,
Bar-Ner, N., Natan, N., Brandeis, R., Elkon, H., Nahum, V.,
Gershonov, E., LaFerla, F. M., & Medeiros, R. (2016). AF710B, a
Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of
Alzheimer’s Disease. Neuro-degenerative
diseases, 16(1-2), 95–110. https://doi.org/10.1159/0004408645
https://www.anavex.com/post/anavex-life-sciences-reports-positive-results-from-phase-1-clinical-trial-of-anavex-3-71
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