Anavex Life Sciences Reports Data Review by the Independent Data Safety Monitoring Board for its Phase 2b/3 Clinical Trial of ANAVEX®2-73 in Patients with Alzheimer’s Disease
October 13 2021 - 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 disorders including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today announced that the Independent Data Safety
Monitoring Board (DSMB) for the Company's Phase 2b/3 Alzheimer’s
disease study of its investigational compound ANAVEX®2-73
(blarcamesine) has completed its recent pre-planned review of the
preliminary Phase 2b/3 study data.
As specified in the protocol, the DSMB reviewed
the interim safety data for the ANAVEX®2-73 Phase 2b/3 Alzheimer’s
disease clinical study ANAVEX®2-73-AD-004 and its Open Label
Extension (OLE) ANAVEX®2-73-AD-EP-004 ATTENTION-AD study.
Upon review of the interim safety data, the DSMB
made the following recommendation:
- The DSMB recommendation is to
continue the studies without modification.
DSMBs are committees commonly used in clinical
trials to protect the interests of the patients and the integrity
of the study data in ongoing trials.
ANAVEX®2-73 activates the sigma-1 receptor
(SIGMAR1). Data suggests that activation of SIGMAR1 results in the
restoration of complete housekeeping function within the body and
is pivotal to restoring neural cell homeostasis and promoting
neuroplasticity.1
PET scan data previously confirmed
dose-dependent target engagement of SIGMAR1 with ANAVEX®2-73.2
The placebo-controlled 509-patient Phase 2b/3
ANAVEX®2-73 clinical study in patients with Alzheimer's disease
achieved full enrollment and includes prespecified SIGMAR1 gene
expression as endpoints using ADAS-Cog (cognition) and ADCS-ADL
(activities of daily living and function) as primary endpoints.3
The Company anticipates topline data in the second half of
2022.
Anavex Life Sciences’ product portfolio includes
small drug molecule lead candidate ANAVEX®2-73 for the treatment of
Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
About ANAVEX®2-73-AD-004 Clinical Study
(ClinicalTrials.gov Identifier: NCT03790709) and OLE
ANAVEX®2-73-AD-EP-004 Clinical Study ATTENTION-AD
(ClinicalTrials.gov Identifier: NCT04314934)
ANAVEX®2-73-AD-004 clinical study is a 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 enrolled 509 patients,
randomized 1:1:1 to two different ANAVEX®2-73 doses or placebo. The
ANAVEX®2-73 Phase 2b/3 study design includes genomic precision
medicine biomarkers identified in the previous ANAVEX®2-73 Phase 2a
study (ANAVEX2-73-002, NCT02244541). 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).4 ANAVEX®2-73-AD-EP-004 is
the 96-week open label extension of the placebo-controlled Phase
2b/3 ANAVEX®2-73 study.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive
degenerative brain disorder that gradually destroys a person's
memory and ability to learn, reason, make judgments, communicate
and carry out daily activities. An estimated 5.7 million Americans
have currently Alzheimer's dementia. Alzheimer’s is the most common
cause of dementia among older adults and is estimated to rank as
the third leading cause of death for older people in the United
States, just behind heart disease and cancer. In 2020, Alzheimer's
and other dementias cost the nation $305 billion. By 2050, these
costs could rise as high as $1.1 trillion.5 There are currently
over 50 million people living with dementia around the world, with
numbers expected to increase to nearly 152 million by 2050.6 Almost
10 million new cases of dementia are diagnosed each year worldwide,
implying one new case every 3 seconds, and a significant increase
in the caregiving burden placed on society and families.7
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),
successfully completed a Phase 2a clinical trial for Alzheimer’s
disease and recently a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 study in adult patients
with Rett syndrome. 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
muscarinic receptors, is a promising clinical stage 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, Instagram 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:Andrew J.
BarwickiInvestor RelationsTel: 516-662-9461Email:
andrew@barwicki.com
1 Advances in Experimental Medicine and Biology Volume 964
(2017) Sigma Receptors: Their Role in Disease and as Therapeutic
Targets.2 Reyes ST et al. Effects of the sigma-1 receptor agonist
blarcamesine in a murine model of fragile X syndrome:
neurobehavioral phenotypes and receptor occupancy. Sci Rep. 2021
Aug 25;11(1):17150. doi: 10.1038/s41598-021-94079-7. PMID:
34433831; PMCID: PMC8387417.3 ClinicalTrials.gov Identifier:
NCT03790709.4 Hampel H. et al. (2020). A precision medicine
framework using artificial intelligence for the identification and
confirmation of genomic biomarkers of response to an Alzheimer's
disease therapy: Analysis of the blarcamesine (ANAVEX2‐73) Phase 2a
clinical study. Alzheimer's & Dementia: Translational Research
& Clinical Interventions, 6(1), e12013.5
https://www.nia.nih.gov/health/alzheimers;
https://www.alz.org/alzheimers-dementia/facts-figures.6 Alzheimer's
Disease International. World Alzheimer Report 2019.
https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf.7 AARP.
2020 Report: Caregiving in the U.S.
https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf.
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