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
(AD), Parkinson’s disease (PD), Rett syndrome and other central
nervous system (CNS) diseases, today announced results from the
proof of concept Phase 2 controlled trial evaluating the safety,
tolerability, and efficacy of ANAVEX®2-73 (blarcamesine) in
patients with Parkinson’s disease dementia (PDD).
The study found that ANAVEX®2-73 (blarcamesine)
was safe and well tolerated in oral doses up to 50 mg once daily.
The results show clinically meaningful, dose-dependent, and
statistically significant improvements in the Cognitive Drug
Research (CDR) computerized assessment system analysis. The study
confirmed the precision medicine approach of targeting SIGMAR1 as a
genetic biomarker of response to ANAVEX®2-73 (blarcamesine).
The ANAVEX®2-73-PDD-001 study was an
international, double-blind, multicenter, placebo-controlled Phase
2 clinical study and randomized 132 patients with PDD equally to
target doses of 30mg, 50mg ANAVEX®2-73 (blarcamesine) or placebo,
respectively. In addition to safety and cognitive efficacy, sleep
function was assessed during the study at week 8 and week 14.
ANAVEX®2-73-PDD-001 study results will be
submitted for presentation at a medical conference and for
publication in a peer-reviewed medical journal. Anavex is planning
a pivotal trial of ANAVEX®2-73 (blarcamesine) in Parkinson’s
disease dementia after submitting the results of the study to the
FDA to obtain regulatory guidance.
Dr. Jaime Kulisevsky Bojarski, MD, PhD, Full
Professor of Neurology & Vice-Dean Faculty of Medicine
Autonomous University of Barcelona and Director of the Movement
Disorders Unit, Department of Neurology, Sant Pau Hospital and
Principal Investigator in the trial, commented, "As the first
double-blind trial of ANAVEX®2-73 (blarcamesine) in PDD, this
proof-of-concept study provides extremely encouraging data. PDD can
be debilitating with significant co-morbidities. New therapies are
urgently needed to alleviate this suffering and disability. There
has not been a mechanistically novel medication approved for PDD in
over 20 years."
“I am very pleased to see the promising results
of the ANAVEX®2-73-PDD-001 trial, providing significant
improvements in cognitive function accompanied by a favorable
safety and tolerability profile,” said Dag Aarsland, MD, PhD,
Professor and the Head of Department of Old Age Psychiatry at the
Institute of Psychiatry, Psychology & Neuroscience, King’s
College London, UK. “Cognitive impairment of patients with
Parkinson’s disease dementia is very distressing to patients and
their families and is associated with greater risk of
institutionalization and accelerated progression to severe dementia
and death. Given the limited options of adequate treatments for
Parkinson’s disease dementia, and the safety concerns and modest or
uncertain efficacy of currently used off-label treatments, the
ANAVEX®2-73 (blarcamesine) study results represent a meaningful
step forward toward urgently needed treatment for this serious
complication of Parkinson’s disease.”
“We would like to thank all the patients and
participating families as well the investigators and clinical site
coordinators for their dedication to this stud,” said Christopher
U. Missling, PhD, President and Chief Executive Officer of Anavex.
"Our strategy to advance ANAVEX®2-73 (blarcamesine) with focus on
Precision Medicine has been validated in this study of patients
with significant cognitive impairment and we are looking forward to
the next clinical data readout of ANAVEX®2-73 (blarcamesine) in
Rett syndrome and Alzheimer’s disease, indications where cognitive
impairment is also prevalent.”
After completing the trial, participants were
able to enroll in a voluntary 48-week open-label extension study,
ANAVEX®2-73-PDD-EP-001, which continues to assess safety, long term
efficacy and changes in gut microbiota.1
ANAVEX®2-73 (blarcamesine) is an orally
available, small-molecule activator of the sigma-1 receptor, which
has been shown to be pivotal to restoring neural cell homeostasis
and promoting neuroplasticity.2
Conference Call Information
Anavex will host a conference call and webcast
today at 8:30 AM Eastern Time to discuss the topline results of the
ANAVEX®2-73-PDD-001 trial of ANAVEX®2-73 (blarcamesine) in
Parkinson’s disease dementia. To participate in the live conference
call, please dial 1 (866) 939-3921 (toll-free domestic) or 1 (678)
302-3550 (international) and use the passcode 49986272. The webcast
can be accessed at https://wsw.com/webcast/cc/avxl15/1496358 and on
the Company’s website at www.anavex.com. A replay of the webcast
will be available for approximately 30 days following the live
event.
About Parkinson’s Disease Dementia (PDD)
Parkinson’s disease is a fairly common
neurological disorder in older adults, estimated to affect nearly 2
percent of those older than age 65. The Parkinson’s Foundation
estimates that 1 million Americans have Parkinson’s disease. It is
estimated that up to 80 percent of those with Parkinson’s disease
eventually experience Parkinson’s disease dementia. The brain
changes caused by Parkinson’s disease begin in a region that plays
a key role in movement. As Parkinson’s brain changes gradually
spread, they often begin to affect mental functions, including
memory and the ability to pay attention, make sound judgments and
plan the steps needed to complete a task.3
About ANAVEX®2-73
(blarcamesine)
ANAVEX®2-73 (blarcamesine) activates the Sigma-1
receptor (S1R) protein, which serves as a molecular chaperone and
functional modulator involved in restoring homeostasis. In a Phase
2a Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) has
shown dose dependent improvement in exploratory endpoints of
cognition (MMSE) and activities of daily living (ADCS-ADL). Full
genomic analysis of ANAVEX®2-73 (blarcamesine) Phase 2a AD patients
was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 PDD study
design includes genomic biomarkers identified in the ANAVEX®2-73
(blarcamesine) Phase 2a AD study. Studies of ANAVEX®2-73
(blarcamesine) in a disease modifying model of Parkinson’s disease
indicates that ANAVEX®2-73 (blarcamesine) is well tolerated,
induces significant motor recovery (p<0.05), induces
neurohistological restoration (p<0.05) and reduces microglial
activation (p<0.05), a potential biomarker of Parkinson’s
disease. Behavioral patterns were completely normal, meaning no
signs of either dystonia or stereotypic behaviors were detected in
animals receiving the treatment. These studies were funded by The
Michael J. Fox Foundation for Parkinson’s Research.
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 ClinicalTrials.gov Identifier: NCT045752592 Advances in
Experimental Medicine and Biology Volume 964 (2017) Sigma
Receptors: Their Role in Disease and as Therapeutic Targets.3
Source: www.alz.org/dementia/parkinsons-disease-symptoms
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