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 positive top-line results from its
Phase 1 clinical trial of ANAVEX®3-71, an oral small molecule
agonist of both SIGMAR1 and CHRM1 (Cholinergic Receptor Muscarinic
M1) in development for the treatment of neurodegenerative diseases
including Frontotemporal Dementia (FTD), for which ANAVEX®3-71 has
been granted Orphan Drug Designation (ODD) by the FDA.
The study was a double-blind, randomized,
placebo-controlled, Phase 1 trial to evaluate safety and
tolerability, and pharmacokinetics (PK) of oral escalating doses of
ANAVEX®3-71 including effects of food and gender in healthy
volunteers.
ANAVEX®3-71 was well tolerated in all cohorts
receiving ANAVEX®3-71 in single doses ranging from 5 mg to 200 mg
daily with no serious adverse events (SAEs) and no significant lab
abnormalities in any subject. In the study, ANAVEX®3-71 exhibited
linear pharmacokinetics. Its pharmacokinetics was also dose
proportional for doses up to 160 mg. Gender had no effect on the PK
of the drug and food had no effect on the bioavailability of
ANAVEX®3-71. The study also met the secondary objective of
characterizing the effect of ANAVEX®3-71 on electrocardiogram (ECG)
parameters. There were no clinically significant ECG parameters
throughout the study. Participant QTcF measures were normal across
all dose groups with no difference between ANAVEX®3-71 and
Placebo.
“We are pleased with the Phase 1 trial results
for ANAVEX®3-71 and are eager to advance ANAVEX®3-71 into Phase 2,”
said Christopher U Missling, PhD, President and Chief Executive
Officer of Anavex. “These encouraging results provide a proof of
concept of our SIGMAR1 product platform and helps validate Anavex’s
approach to CNS target selection and drug discovery and increases
Anavex’ confidence in the potential of our precision medicine
technology to address serious neurodegenerative diseases.”
Based on these results, and ANAVEX®3-71
pre-clinical profile, the Company intends to advance ANAVEX®3-71
into a biomarker-driven clinical development dementia program for
the treatment of FTD, schizophrenias and Alzheimer’s disease,
evaluating longitudinal effect of treatment with ANAVEX®3-71
initiating in 2022. Anavex believes the results of this study,
could serve as the basis for advancing into respective registration
studies in the U.S.
Conference Call Information
Anavex Life Sciences will host a webcast today
at 8:30 a.m. ET to discuss the top-line results from the Phase 1
clinical trial of ANAVEX®3-71 in healthy volunteers. The live
webcast can be accessed on the investor page of Anavex’s website at
www.anavex.com. A replay of the webcast will be available and will
be archived for up to 30 days.
About the Phase 1 trial with
ANAVEX®3-71
The phase 1 clinical trial was a prospective
double-blind, randomized, placebo-controlled study. A total of 42
healthy male and female subjects were included. Single escalating
doses of ANAVEX®3-71 were administered in order to evaluate the
safety, tolerability, and pharmacokinetics (PK) of ANAVEX®3-71 and
the effects of food and gender on its PK in healthy volunteers.
This study will be followed by longer duration dosing including
patients with FTD, schizophrenias and Alzheimer’s disease
incorporating efficacy and disease biomarker measures. More
information about the Phase 1 trial is available on
clinicaltrials.gov, under ClinicalTrials.gov Identifier:
NCT04442945.
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.1
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 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 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/10.1159/000440864
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