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 reported new data that established
ANAVEX®2-73 to be a preventive treatment in the pharmacological
model of Alzheimer's disease (AD). Pre-treatment with ANAVEX®2-73,
repeated once daily for one week before the Aβ (Abeta) challenge
was protective in the Aβ25-35 peptide model of Alzheimer’s disease
in mice. ANAVEX®2-73 significantly and dose-dependently prevented
Aβ25-35-induced biomarker-correlated cognitive impairments, which
were assessed one week after the Aβ (Abeta) insult during which no
further ANAVEX®2-73 treatment took place.
ANAVEX®2-73 activates the sigma-1 receptor
(SIGMAR1). Data suggests that activation of SIGMAR1 results in the
restoration of complete housekeeping function within the body and
is pivotal to restoring neural cell homeostasis and promoting
neuroplasticity.1 SIGMAR1 also promotes autophagy and results in
the degradation of amyloid-beta precursor protein (APP) thereby
inhibiting Aβ production2.
"We are excited about this data, which indicates
the potential expansion for the ANAVEX®2-73 platform to find an
effective Alzheimer's prevention therapy, which might benefit the
entire field," said Christopher U. Missling, PhD, President &
Chief Executive Officer of Anavex. "In addition to finding
treatment options for Alzheimer’s disease, we are also striving to
find effective prevention therapies for this devastating disease,
and this data might help advance this endeavor to address an area
of high unmet medical need."
Data from this study will be submitted later
this year for presentation at a scientific medical meeting.
Previously, a publication in Neuropharmacology
noted that in a clinical study (ANAVEX2-73-002) of Alzheimer’s
disease patients, 57 weeks of oral once daily ANAVEX®2-73 treatment
showed patients improved cognition scores by +2.0 points on MMSE, a
9% mean improvement from baseline to 57 weeks, corresponding to a
calculated ADAS-Cog score change of -3.4 (improvement). In these
same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a
7% mean improvement from baseline to 57 weeks.3
An extension of the published study
(ANAVEX2-73-003) demonstrated that for the same patients at week 70
MMSE scores improved by +3.0, a 14% improvement from baseline,
corresponding to a calculated ADAS-Cog score change of -5.1
(improvement). In these same patients, ANAVEX®2-73 also improved
ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to
70 weeks. The mean MMSE and ADCS-ADL baseline scores for these
patients in this study were 22.3 and 71.1, respectively.4,5
This data seems to be consistent with the effect
of ANAVEX®2-73 on cognition assessed in the recently completed
placebo-controlled Phase 2 study of 132 patients with Parkinson’s
disease dementia (ANAVEX2-73-PDD-001) with once-daily
administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and
placebo for 14 weeks. The observed statistically significant
improvement of CDR system Episodic Memory of +42.22 between 50 mg
ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).6 CDR
system Episodic Memory has been shown to be highly correlated (70%)
with the ADAS-Cog score (r = 0.7).7 The calculated corresponding
ADAS-Cog mean change from baseline score is -1.9 (improvement) for
patients in the 50 mg dose group, an 8% mean improvement from
baseline to 14 weeks. The difference between the ANAVEX®2-73 group
and the placebo group in the change from baseline at 14 weeks was a
4.0-point improvement of calculated corresponding ADAS-Cog score (p
= 0.015).
The Company recently announced that it has
exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine)
double-blind, placebo-controlled late-stage Phase 2b/3 study
(ANAVEX2-73-004) in Alzheimer’s disease.
Anavex Life Sciences’ product portfolio platform
includes orally available 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 frontotemporal
dementia.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive
degenerative brain disorder that gradually destroys a person's
memory and ability to learn, reason, make judgments, communicate
and carry out daily activities. An estimated 5.7 million Americans
currently have Alzheimer's dementia. Alzheimer’s is the most common
cause of dementia among older adults and is estimated to rank as
the third leading cause of death for older people in the United
States, just behind heart disease and cancer. In 2020, Alzheimer's
and other dementias cost the nation approximately $305 billion. By
2050, these costs could rise as high as $1.1 trillion.8 There are
currently over 50 million people living with dementia around the
world, with numbers expected to increase to nearly 152 million by
2050.9 Almost 10 million new cases of dementia are diagnosed each
year worldwide, implying one new case every 3 seconds, and a
significant increase in the caregiving burden placed on society and
families.10
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of 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, pain and various types of
cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine),
successfully completed a Phase 2a clinical trial for Alzheimer’s
disease and recently a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 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 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
Targets2 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):e11102.3 Hampel H, Vergallo A, Caraci F, Cuello AC,
Lemercier P, Vellas B, Giudici KV, Baldacci F, Hänisch B, Haberkamp
M, Broich K, Nisticò R, Emanuele E, Llavero F, Zugaza JL, Lucía A,
Giacobini E, Lista S; Alzheimer Precision Medicine Initiative.
Future avenues for Alzheimer’s disease detection and therapy:
liquid biopsy, intracellular signaling modulation, systems
pharmacology drug discovery. Neuropharmacology. 2021 Mar
1;185:108081. doi: 10.1016/j.neuropharm.2020.108081. Epub 2020 May
11. PMID: 32407924.4 Hampel H. et al., 2018. Full genomic analysis
of ANAVEX®2-73 phase 2a Alzheimer’s disease study identifies
biomarkers enabling targeted therapy and a precision medicine
approach. Alzheimer’s & Dementia 14, P1519–P1520.
https://doi.org/10.1016/j.jalz.2018.07.027.5 Hampel H. et al.
(2020). A precision medicine framework using artificial
intelligence for the identification and confirmation of genomic
biomarkers of response to an Alzheimer's disease therapy: Analysis
of the blarcamesine (ANAVEX2‐73) Phase 2a clinical study.
Alzheimer's & Dementia: Translational Research & Clinical
Interventions, 6(1), e12013.6
https://www.anavex.com/proof-of-concept-controlled-phase-2-clinical-trial-data-evaluating-anavex2-73-blarcamesine-in-parkinsons-disease-dementia-presented-at-ctad-2020-conference/.7
Wesnes K. et al., Computerized cognition assessment during
acetylcholinesterase inhibitor treatment in Alzheimer’s disease.
Acta Neurol Scand 2010; 122:270–7.8
https://www.nia.nih.gov/health/alzheimers;
https://www.alz.org/alzheimers-dementia/facts-figures.9 Alzheimer's
Disease International. World Alzheimer Report 2019.
https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf.10
AARP. 2020 Report: Caregiving in the U.S.
https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf.
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