Anavex Life Sciences Receives Approval to Initiate Phase 2 Clinical Trial of ANAVEX®2-73 for the Treatment of Parkinson’s ...
July 09 2018 - 6:00AM
Primary Endpoint Cognition with Secondary
Endpoints Parkinsonian Motor Symptoms and Sleep Function during
14-Week Study
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 diseases, today announced
that the Company has received approval from the Spanish Agency for
Medicinal Products and Medical Devices (AEMPS), to initiate its
Phase 2, double-blind, placebo-controlled 14-week trial of the
safety and efficacy of ANAVEX®2-73 for the treatment of Parkinson’s
disease dementia (PDD). The Phase 2 study is scheduled to initiate
enrollment of approximately 120 patients, randomized 1:1:1 to two
different ANAVEX®2-73 doses or placebo, within the next few months,
in up to 24 clinical study sites.
Professor Dag Aarsland, MD, Head of Department
of Old Age Psychiatry at the Institute of Psychiatry, Psychology
and Neuroscience at King’s College London commented: “Since as many
as 80 percent of people with Parkinson’s will experience
Parkinson’s disease dementia and treatment options are limited,
this study is using the latest generation of diagnostic and
treatment developments in Parkinson’s disease dementia and I am
looking forward to a potential contribution to the future
development of this significant unmet need.”
The Company ‘s trial design for the Phase 2
program in PDD includes genomic, precision medicine-based
biomarkers identified from patients previously treated with
ANAVEX®2-73. This novel approach has informed clinical trial
designs and is expected to yield insight as to potential
responders, and to enrich future regulatory submissions.
“We are excited about the approval to initiate
the Phase 2 study of ANAVEX®2-73 for the treatment of Parkinson’s
disease dementia, which will focus on the effect of ANAVEX®2-73 on
both the cognitive and motor impairment of Parkinson’s disease,”
said Christopher U Missling, PhD, President and Chief Executive
Officer of Anavex. “We continue leveraging our precision medicine
approach to drug development to provide intelligence beyond many
traditional neurology trials to disease areas with high unmet
needs.”
About Parkinson’s disease with 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 50 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.[1][1] Source:
www.alz.org/dementia/parkinsons-disease-symptoms
About ANAVEX®2-73
ANAVEX®2-73 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 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 Phase 2a AD patients was performed. The ANAVEX®2-73
Phase 2 PDD study design includes genomic biomarkers identified in
the ANAVEX®2-73 Phase 2a AD study. Studies of ANAVEX®2-73 in a
disease modifying model of Parkinson’s disease indicates that
ANAVEX®2-73 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 diseases including
Alzheimer’s disease, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX®2-73, recently completed a successful Phase 2a clinical
trial for Alzheimer’s disease. 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 to develop
ANAVEX®2-73 for the treatment of Parkinson’s disease. The grant
fully funded a preclinical study. ANAVEX®3-71, which targets
sigma-1 and M1 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
neuroinflammation and mitochondrial dysfunction. 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:Scott
GordonCore IRscottg@coreir.com
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