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
(AD), Parkinson’s disease (PD), Rett syndrome and other central
nervous system (CNS) diseases, today announced additional details
on and presented the results from the proof of concept Phase 2
controlled trial evaluating the safety, tolerability, and efficacy
of ANAVEX®2-73 (blarcamesine) in patients with Parkinson’s disease
dementia (PDD) at the 13th international conference on Clinical
Trials on Alzheimer’s Disease (CTAD). CTAD is an annual conference
focused on Alzheimer’s research and development and takes place
this year as a virtual event on November 4-7th, 2020.
Details of the Late-breaking
Presentation:Title:
“ANAVEX®2-73
(blarcamesine) Currently in Phase
2b/3 Early Alzheimer’s Disease (AD): Analysis of Cognitive Outcome
Measures Relevant to AD of Double-blind, Multicenter,
Placebo-controlled Phase 2 Clinical Trial in 132 Patients with
Parkinson’s Disease Dementia”
Presentation Type: |
Late-Breaking, Oral Presentation (LB25) |
Presenter: |
Dag Aarsland, MD, PhD - King’s College London, UK |
Date/Time: |
November 6, 2020, 10:45 am EST |
The study found that ANAVEX®2-73 (blarcamesine)
was well tolerated in oral doses up to 50 mg once daily. The
results showed clinically meaningful, dose-dependent, and
statistically significant improvements in the Cognitive Drug
Research (CDR) computerized assessment system analysis. The study
validated the precision medicine approach of targeting SIGMAR1 as a
genetic biomarker of response to ANAVEX®2-73 (blarcamesine),
confirming that ANAVEX®2-73 (blarcamesine) acts through SIGMAR1
activation. These results support continued development in PDD / PD
as well as the currently ongoing Phase 2 and Phase 2/3 clinical
studies with ANAVEX®2-73 (blarcamesine) in Rett syndrome1 and
Alzheimer’s disease2.
Highlights of the study results:
- Broad and statistically significant
improvements in CDR system Cognitive Domain of Attention assessed
by Choice Reaction Time (p = 0.039) and Digital Vigilance (p =
0.008) and CDR system Episodic Memory (p = 0.047), representing
complex cognitive tasks with impact on quality of life such as
making a choice between similar objects and remembering daily
personal experiences, which are mostly impaired in both PD and
AD.3
- Statistically significant
dose-dependent (p = 0.003) improvement of Episodic Memory, which
has been shown to be highly correlated (70%) with the Alzheimer’s
Disease Assessment Scale–Cognitive score (ADAS-Cog; r = 0.7).4
- ANAVEX®2-73 (blarcamesine) does not
impair sleep and has a positive effect on REM sleep behavior
disorder.
- ANAVEX®2-73 (blarcamesine) was
generally safe, well tolerated, and improved safety profile
compared to dementia drugs associated with typical adverse
effects.
The presentation is available on the Anavex
website (www.anavex.com).
The ANAVEX®2-73-PDD-001 study was an
international, double-blind, multicenter, placebo-controlled proof
of concept Phase 2 clinical study that randomized 132 patients with
PDD equally to target doses of 30mg, 50mg ANAVEX®2-73
(blarcamesine) or placebo, respectively. In addition to safety and
cognitive efficacy, sleep function was assessed during the study at
week 8 and week 14.
ANAVEX®2-73-PDD-001 study results will be
submitted for publication in a peer-reviewed medical journal.
Anavex is planning a pivotal trial of ANAVEX®2-73 (blarcamesine) in
Parkinson’s disease dementia after submitting the results of the
study to the FDA to obtain regulatory guidance.
“I am very intrigued to see the promising
results of the ANAVEX®2-73-PDD-001 trial, providing significant
improvements in cognitive function accompanied by a favorable
safety and tolerability profile,” said Dag Aarsland, MD, PhD,
Professor and the Head of Department of Old Age Psychiatry at the
Institute of Psychiatry, Psychology & Neuroscience, King’s
College London, UK. “The ANAVEX®2-73 (blarcamesine) study results
represent a meaningful step forward toward urgently needed
treatment for this serious complication of Parkinson’s disease
given that cognitive impairment of patients with Parkinson’s
disease dementia is very distressing to patients and their families
and is associated with greater risk of institutionalization and
accelerated progression to severe dementia and death.”
Dr. Jaime Kulisevsky, MD, PhD, Full Professor of
Neurology & Vice-Dean Faculty of Medicine Autonomous University
of Barcelona and Director of the Movement Disorders Unit,
Department of Neurology, Sant Pau Hospital and Principal
Investigator in the trial, commented, "PDD is a debilitating
disorder with significant co-morbidities and there has not been a
mechanistically novel medication approved for PDD in over 20 years.
Hence, new therapies are urgently needed to alleviate this
suffering and disability. As the first double-blind trial of
ANAVEX®2-73 (blarcamesine) in PDD, this proof-of-concept study
provides very encouraging and clinically relevant data."
Christopher U Missling, PhD, President &
Chief Executive Officer of Anavex, "Our strategy has been
consistently to advance ANAVEX®2-73 (blarcamesine) with focus on
Precision Medicine and to validate this approach in clinical
studies in patients with significant cognitive impairments. We are
pleased with these PDD study results that will be further
supplemented by actigraphy movement data and whole genome exome DNA
and RNA data. Finally, we would like to thank all the patients and
participating families as well the investigators and clinical site
coordinators for their dedication to this study."
After completing the trial, participants were
able to enroll in a voluntary 48-week open-label extension study,
ANAVEX®2-73-PDD-EP-001, which continues to assess safety, long term
efficacy and changes in gut microbiota.5
ANAVEX®2-73 (blarcamesine) is an orally
available, small-molecule activator of the sigma-1 receptor
(SIGMAR1), which has been shown to be pivotal to restoring neural
cell homeostasis and promoting neuroplasticity.6
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.7
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 study in 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 animal 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 ClinicalTrials.gov
Identifiers: NCT03758924, NCT03941444, NCT043044822
ClinicalTrials.gov Identifiers: NCT03790709, NCT027568583 Mahurin,
R. K., & Pirozzolo, F. J. (1993). Application of Hick’s law of
response speed in Alzheimer and Parkinson diseases. Perceptual and
Motor Skills, 77(1), 107–1134 Wesnes K, Edgar C, Andreasen N, Annas
P, Basun H, Lannfelt L, et al. Computerized cognition assessment
during acetylcholinesterase inhibitor treatment in Alzheimer’s
disease. Acta Neurol Scand 2010; 122:270–75 ClinicalTrials.gov
Identifier: NCT045752596 Advances in Experimental Medicine and
Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease
and as Therapeutic Targets.7
Source: https://www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia
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