Anavex Life Sciences Announces Achievement of Enrollment Target for the ANAVEX®2-73 (blarcamesine) Phase 2 Parkinson’s Dis...
January 27 2020 - 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) disorders, today announced that it has met its enrollment
target for the ANAVEX®2-73 (blarcamesine) Phase 2 study in
Parkinson’s Disease Dementia (PDD). The Company expects to announce
topline results from this study by mid-2020.
ANAVEX®2-73 (blarcamesine) is an orally
available, small-molecule activator of the sigma-1 receptor which,
data suggest, is pivotal to restoring neural cell homeostasis and
promoting neuroplasticity.1
The study enrolled over 120 patients at 20 sites
across Spain (Europe) along with 3 sites in Australia. This
multi-center, double-blind clinical trial is measuring efficacy,
tolerability, and safety of two different once daily oral
ANAVEX®2-73 (blarcamesine) doses or placebo.
The ANAVEX®2-73 (blarcamesine) Phase 2 PDD study
design incorporates genomic precision medicine biomarkers. Primary
and secondary endpoints will assess cognition and Parkinsonian
motor symptoms and sleep function during the 14-week study.2 The
efficacy assessments include the Cognitive Drug Research (CDR)
Computerized Assessment System, MDS-UPDRS (Motor Scores) and
incidence of Sleep Disorders Symptom Checklist (SDS-CL-25).
ANAVEX®2-73 (blarcamesine) previously demonstrated in a Phase 2a
Alzheimer’s disease study dose dependent improvement in exploratory
endpoints of cognition (ERP/EEG, Cogstate, Mini-Mental State
Examination - MMSE) within 5 weeks. To offer eligible participants
of the Phase 2 PDD study access to ANAVEX®2-73 (blarcamesine),
participants completing the trial may enroll in a voluntary 48-week
open-label extension study.
“A significant unmet need exists currently for
Parkinson’s disease patients since up to 80% of Parkinson’s
patients develop dementia, and we are excited to have fully
enrolled this study for ANAVEX®2-73 (blarcamesine), meeting the
high-end of our targeted range," said Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. "Given
ANAVEX®2-73’s (blarcamesine) oral route of administration we
believe it has the potential to deliver broad clinical
utility."
About Parkinson’s Disease 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 up 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.3
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. In a Phase
2a Alzheimer’s disease (AD) study, ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) Phase 2a AD patients
was performed. The ANAVEX®2-73 (blarcamesine) Phase 2 PDD study
design includes genomic biomarkers identified in the ANAVEX®2-73
(blarcamesine) Phase 2a AD study. Studies of ANAVEX®2-73
(blarcamesine) in a disease modifying model of Parkinson’s disease
indicates that ANAVEX®2-73 (blarcamesine) 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 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
1 Advances in Experimental Medicine and Biology Volume 964
(2017) Sigma Receptors: Their Role in Disease and as Therapeutic
Targets.
2 ClinicalTrials.gov Identifier: NCT03774459.
3
Source: https://www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia
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