First Patient Enrolled in Anavex Life Sciences Phase 2 Clinical Trial of ANAVEX®2-73 for the Treatment of Parkinson’s Dise...
October 30 2018 - 7:00AM
Study will incorporate genomic precision medicine
ANAVEX®2-73-specific biomarkers
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 including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced that it has enrolled the first
patient in its Phase 2 double-blind, randomized,
placebo-controlled, 14-week safety and efficacy trial of
ANAVEX®2-73 for the treatment of Parkinson’s disease dementia
(PDD). The Phase 2 study will enroll approximately 120 patients,
randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo.
“Parkinson’s disease is an already prevalent
disease among older individuals that is poised to become a much
greater public health problem around the globe in the coming
decades and is now appreciated commonly to cause cognitive
impairment, including dementia, and behavioral changes,” commented
Professor Jaime Kulisevsky, MD, PhD Vice Dean Faculty of Medicine
and Full Professor of Neurology at the Autonomous University of
Barcelona and Director of the Movement Disorders Unit of the Sant
Pau Hospital in Barcelona, Spain, and Principal Investigator of the
Phase 2 study.
The ANAVEX®2-73 Phase 2 study design
incorporates genomic precision medicine biomarkers identified in
the ANAVEX®2-73 Phase 2a AD study. Primary and secondary endpoints
will assess safety and both cognition and Parkinsonian motor
symptoms and sleep function during 14-week study. ANAVEX®2-73 Phase
2a Alzheimer’s disease study previously demonstrated dose dependent
improvement in exploratory endpoint of cognition (MMSE) within 5
weeks.
“We are very pleased to initiate our first
patient enrollment into the Parkinson’s disease dementia Phase 2
study of ANAVEX®2-73,” said Christopher U Missling, PhD, President
and Chief Executive Officer of Anavex. “This is an important step
toward achieving clinical data for the second indication initiating
this year for ANAVEX®2-73 also incorporating genomic precision
medicine biomarkers.”
About the ANAVEX®2-73 Parkinson’s
Disease Dementia Clinical Phase 2 Study
For patients within Spain who wish to be
considered for participation in this study, please visit the Ethics
Committee (EC)-approved website,
www.pddtrial.com. Patients or caregivers
interested in the study can download a simple screening
questionnaire to facilitate their discussion with their local
physician.
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, 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, 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, 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 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
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Apr 2023 to Apr 2024