Anavex Life Sciences Receives Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73 (blarcames...
04 June 2020 - 9:00PM
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,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced that it has received a No Objection
Letter from Health Canada as well as Clinical Trial Authorization
(CTA) from the Medicines and Healthcare products Regulatory Agency
(MHRA) in the United Kingdom (UK) to expand the Phase 2b/3
double-blind, randomized, placebo-controlled safety and efficacy
trial (Study ANAVEX®2-73-AD-004) of ANAVEX®2-73 (blarcamesine) for
the treatment of early Alzheimer’s disease into Canada and UK,
respectively.
The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004
(ClinicalTrials.gov NCT03790709) of ANAVEX®2-73 (blarcamesine)
using biomarker and precision medicine in 450 patients with early
Alzheimer’s disease is ongoing and currently over 50% enrolled.
“We are excited to receive the regulatory
approvals for this Phase 2b/3 study for patients seeking treatment
for Alzheimer’s disease,” commented Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. “This expansion
into North America and Europe should accelerate the completion of
the enrollment of the ongoing ANAVEX®2-73-AD-004 Alzheimer’s
disease Phase 2b/3 trial with ANAVEX®2-73 (blarcamesine).”
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. S1R
activation has demonstrated ability to reduce key
pathophysiological signs of Alzheimer’s disease: beta amyloid,
hyperphosphorylated tau, and increased inflammation. In the Phase
2a 57-week Alzheimer’s disease (AD) ANAVEX®2-73-002
(ClinicalTrials.gov NCT02244541) study, ANAVEX®2-73 (blarcamesine)
has shown dose dependent improvement in exploratory endpoints of
cognition (MMSE) and function (ADCS-ADL). Its open-label extension
study ANAVEX®2-73-003 (ClinicalTrials.gov NCT02756858) for an
additional 208 weeks included full genomic analysis of patients
with Alzheimer’s disease treated with ANAVEX®2-73 (blarcamesine). A
48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov
NCT03790709) of ANAVEX®2-73 (blarcamesine) in 450 patients with
early Alzheimer’s disease is ongoing and currently over 50%
enrolled.
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
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