First Patient Enrolled in Anavex Life Sciences Phase 2b/3 Clinical Trial of ANAVEX®2-73 for the Treatment of Early Alzheimer...
August 28 2018 - 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 diseases including Alzheimer’s disease, Rett
syndrome and other central nervous system (CNS) diseases, today
announced that it has enrolled the first patient in its Phase 2b/3
double-blind, randomized, placebo-controlled, 48-week safety and
efficacy trial of ANAVEX®2-73 for the treatment of early
Alzheimer’s disease. The Phase 2b/3 study will enroll approximately
450 patients, randomized 1:1:1 to two different ANAVEX®2-73 doses
or placebo. As part of the planned international study, North
American sites will be added.
“We are very excited to have now commenced the
study, having enrolled our first patient. This highly-anticipated
trial has generated great interest in Australia and overseas, and
we now look forward to a phase of rapid recruitment of those who
have registered their intent to participate,” commented A/Prof
Stephen Macfarlane, FRANZCP, Head of Clinical Services for The
Dementia Centre, HammondCare, and Principal Investigator of the
Phase2b/3 study.
The ANAVEX®2-73 Phase 2b/3 study design
incorporates genomic precision medicine biomarkers identified in
the ANAVEX®2-73 Phase 2a study. Primary and secondary endpoints
will assess safety and both cognitive and functional efficacy,
measured through ADAS-Cog, ADCS-ADL and CDR-SB. ANAVEX®2-73 Phase
2a Alzheimer’s disease study previously demonstrated dose dependent
improvement in exploratory endpoints of cognition (MMSE) and
function (ADCS-ADL).
“We are very pleased to initiate our first
patient enrollment into the Phase 2b/3 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 in regard to the treatment of early Alzheimer’ disease, which
continues to represent an area of very high unmet need for the
growing number of patients globally. Incorporating genomic
precision medicine biomarkers identified in the ANAVEX®2-73 Phase
2a study is an incredibly important aspect of this study and we
look forward to the insights gained through this data.”
About the ANAVEX®2-73 Alzheimer’s
Disease Clinical Phase 2b/3 Study
For patients within Australia who wish
to be considered for participation in this study, please visit the
Ethics Committee (EC)-approved website,
www.anavexaustralia.com. Patient
candidates can register their interest in the study and answer a
few simple screening questions. For those without internet access,
expressions of interest can be registered by calling 02 8437
7355.
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. S1R activation has
demonstrated ability to reduce key pathophysiological signs of
Alzheimer’s disease: beta amyloid, hyperphosphorylated tau, and
increased inflammation. In a Phase 2a Alzheimer’s disease study,
ANAVEX®2-73 has shown dose dependent improvement in exploratory
endpoints of cognition (MMSE) and function (ADCS-ADL). Whole DNA
Exome Sequencing (WES) and RNA expression genomic analysis of
ANAVEX®2-73 Phase 2a Alzheimer’s disease patients was performed.
The ANAVEX®2-73 Phase 2b/3 study design includes genomic precision
medicine biomarkers identified in the ANAVEX®2-73 Phase 2a
study.
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, 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
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