Anavex Life Sciences Receives Approval To Initiate Phase 2b/3 Clinical Trial of ANAVEX®2-73 for the Treatment of Early Alzhe...
July 03 2018 - 6:00AM
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 the Company has received
approval by the Australian Human Research Ethics Committee to
initiate 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 is scheduled to initiate enrollment of
approximately 450 patients, randomized 1:1:1 to two different
ANAVEX®2-73 doses or placebo within the next month. As part of the
planned international study, North American sites will be added.
“We are extremely pleased to gain approval to
initiate the ANAVEX®2-73 Phase 2b/3 study for the treatment of
early Alzheimer’s disease, an area of very high unmet need for the
growing number of patients around the world,” said Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
The ANAVEX®2-73 Phase 2b/3 study design includes
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).
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). Full 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 to develop
ANAVEX®2-73 for the treatment of Parkinson’s disease. The grant
fully funded a preclinical study, which could justify moving
ANAVEX®2-73 into a Parkinson’s disease clinical trial. 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:Meggie
PurcellSolebury Troutmpurcell@soleburytrout.com
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