Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming ANAVEX®3-71 Clinical Cardiovascular Safety
August 07 2023 - 7:30AM
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 a peer-reviewed publication in
Clinical Pharmacology in Drug Development, findings from the
ANAVEX®3-71 first-in-human study which achieved its cardiovascular
safety objectives. The publication is entitled, ‘Concentration-QTc
Relationship from a Single Ascending Dose Study of ANAVEX3-71, a
Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor
Agonist in Development for the Treatment of Frontotemporal
Dementia, Schizophrenia, and Alzheimer's Disease’. 1
The publication reports the cardiodynamic
evaluation part of the single ascending dose study in healthy
participants with the primary objective of assessing the effect of
ANAVEX®3-71 on ECG (electrocardiogram) parameters.
The results from this cardiodynamic evaluation
demonstrated that ANAVEX®3-71 at single ascending doses of 5 to 200
mg had no clinically relevant effects on any of the studied ECG
parameters and hence confirmed the ANAVEX®3-71 preclinical
cardiovascular safety findings. These data also expand the safety
objectives met in this first-in-human study of ANAVEX®3-71, further
supporting its drug development program.
“This published clinical study demonstrates
Anavex’s commitment to advance Anavex’s clinical pipeline including
ANAVEX®3-71 for Schizophrenia, Frontotemporal Dementia, and
Alzheimer's Disease,” said Christopher U Missling, PhD, President
and Chief Executive Officer of Anavex. "We are looking forward to
initiating the Phase 2 clinical trial in Schizophrenia with
ANAVEX®3-71 in the second half of 2023.”
The paper can be accessed online at:
https://pubmed.ncbi.nlm.nih.gov/37515316/.
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 and recently a Phase 2b/3
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.
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 Fadiran EO, Hammond
E, Tran J, Xue H, Chen J, Kaufmann WE, Missling CU, Darpo B.
Concentration-QTc Relationship from a Single Ascending Dose Study
of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1
Muscarinic Receptor Agonist in Development for the Treatment of
Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease.
Clin Pharmacol Drug Dev. 2023 Jul 28. doi: 10.1002/cpdd.1303. Epub
ahead of print. PMID: 37515316.
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