Anavex Life Sciences Announces Initiation of First-in-Human Phase 1 Study of ANAVEX®3-71 (AF710B)
May 21 2020 - 7:00AM
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 the approval by the Australian
Human Research Ethics Committee to initiate the First-in-Human
(FIH) clinical study of ANAVEX®3-71 (AF710B), an
orally-administered small molecule targeting sigma-1 and M1
muscarinic receptors that is designed to be beneficial for
neurodegenerative diseases.
This 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
“We are excited to expand the Anavex clinical
portfolio by entering the clinic with ANAVEX®3-71. Considerable
efforts over the last few years to progress this program through
IND-enabling GLP animal toxicology, manufacturing and drug
formulation development have resulted in an orally available drug
candidate with potential disease-modifying properties for
vulnerable aged patients with serious morbidity and mortality
associated with neurodegeneration,” said Christopher U Missling,
PhD, President and Chief Executive Officer of Anavex. “We are
looking forward to generating the first clinical data on
ANAVEX®3-71.”
About the Phase 1 trial with
ANAVEX®3-71
The phase 1 clinical trial will be a prospective
double-blind, randomized, placebo-controlled study. A total of at
least 36 healthy male and female subjects will be included. Single
escalating doses of ANAVEX®3-71 will be 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 FTD patients and incorporating exploratory efficacy and
disease biomarker measures.
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),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s
disease. ANAVEX®3-71, which targets sigma-1 and muscarinic
receptors, is a promising preclinical 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 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 & Media:Email:
ir@anavex.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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