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 the presentation of Phase 2
clinical biomarker data from the ANAVEX®2-73-PDD-001 Parkinson’s
Disease Dementia (PDD) study at AD/PD™ 2022 International
Conference on Alzheimer’s & Parkinson’s Diseases and related
neurological disorders, taking place in Barcelona, Spain, and
virtually on March 15–20, 2022.
The poster presentation titled, “ANAVEX®2-73
(blarcamesine) - Analysis of Movement (MDS-UPDRS) and Cognitive
(CDR System) Pharmacodynamic-Biomarker Outcome Measures of
Placebo-Controlled Phase 2 Trial in 132 Parkinson’s Disease
Dementia Patients” is being presented by the Principal Investigator
of the trial, 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.
MDS-UPDRS1 Total score improved significantly by
-14.51 (p=0.034) for patients treated with ANAVEX®2-73 high oral
once-daily dose compared to placebo. The improvement is clinically
relevant corresponding to a relative improvement of 18.9% over 14
weeks.
Balanced and global improvements were observed
within all MDS-UPDRS sub-scores Part I-IV:
- MDS-UPDRS Part I: 92.23% items
improved (12 items out of 13)
- MDS-UPDRS Part II: 76.92% items
improved (10 items out of 13)
- MDS-UPDRS Part III: 88.23% items
improved (30 items out of 34)
- MDS-UPDRS Part IV: 71.42% items
improved (5 items out of 7)
MDS-UPDRS Total score is defined by the sum of
all Parts:
- Part I: Non-motor Experiences of
Daily Living
- Part II: Motor Experiences of Daily
Living
- Part III: Motor Examination
- Part IV: Motor Complications
SIGMAR1 mRNA expression significantly increased
in ANAVEX®2-73-treated patients vs placebo (p=0.035) over the
course of treatment and was significantly associated with
improvements of MDS-UPDRS scores and cognitive efficacy endpoints
CDR system.
Dr. Jaime Kulisevsky, MD, PhD, Principal
Investigator of 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. I am impressed with the robust
improvement of the MDS-UPDRS across all sub-score parts I-IV
coupled with the biomarker correlated outcome measures and I
support the implementation of the ANAVEX®2-73 Phase 3 studies in
Parkinson's disease and Parkinson's disease dementia,
respectively.”
Christopher U Missling, PhD, President &
Chief Executive Officer of Anavex, remarked, "ANAVEX®2-73
(blarcamesine) demonstrated dose-dependent efficacy for both motor
impairment (MDS-UPDRS) and cognition (CDR system), which correlated
with SIGMAR1 mRNA as a pharmacodynamic biomarker, respectively.
These results support continued development of ANAVEX®2-73 in
Parkinson’s disease and Parkinson’s disease dementia as well as
currently ongoing Precision Medicine biomarker-driven late-stage
clinical studies in Rett syndrome and Alzheimer’s disease. 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."
The presentation of the Abstract #519 / 336 is
available on the Anavex website (www.anavex.com).
About Parkinson’s Disease (PD)
Parkinson’s disease is a chronic and progressive
neurological disorder that is characterized by well-known motor
symptoms including tremors, stiffness of limbs, slowness of
movements, and difficulties with posture and balance, as well as by
non-motor symptoms. It is the second most common neurological
disorder and approximately one million people in the United States,
and more that 10 million people worldwide, live with this disease.
Parkinson’s disease is more common in people over 60 years of age
and its prevalence is expected to increase significantly as the
average age of the population increases. Current Parkinson’s
treatments are only effective in managing symptoms of the disease,
mainly through the use of levodopa and dopamine agonists. As the
disease progresses and dopaminergic neurons continue to be lost,
these drugs eventually become less effective at treating the
symptoms.
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.2
About ANAVEX®2-73-PDD-001 Clinical Study
(NCT03774459)
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
Parkinson’s disease dementia (PDD) equally (ratio of 1:1:1) to
target doses of 30 mg, 50 mg ANAVEX®2-73 or placebo, respectively.
As previously reported, in addition to prespecified
ANAVEX®2-73-related biomarker of response, SIGMAR1, safety and
cognitive efficacy, MDS-UPDRS, actigraphy and sleep function was
assessed during the study duration of 14 weeks.
Study inclusion required diagnosis of idiopathic
Parkinson's disease (PD) consistent with the UK Parkinson's Disease
Society Brain Bank diagnostic criteria and diagnosis of probable PD
dementia (PDD) according to the Movement Disorder Society Task
Force clinical diagnostic criteria as well as Montreal Cognitive
Assessment (MoCA) score of 13 to 23. DNA and RNA from blood samples
were analyzed using NGS.
Study participants were allowed to be on stable
regimen of anti-Parkinson's disease medications (including
levodopa, dopamine agonists, MAO-B inhibitors, or entacapone).
Treatment with cholinesterase inhibitors, rivastigmine, donepezil
and galantamine (Exelon®, Aricept®, or Reminyl®) were also
permitted.
The study found that ANAVEX®2-73 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, confirming that ANAVEX®2-73
acts through SIGMAR1 activation.
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 does not impair sleep and has a
positive effect on REM sleep behavior disorder.
ANAVEX®2-73 was generally safe, well tolerated,
and improved safety profile compared to dementia drugs associated
with typical adverse effects.
After completing the ANAVEX®2-73-PDD-001 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
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),
has successfully completed a Phase 2a clinical trial for
Alzheimer’s disease, a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and both a Phase 2 and a Phase 3 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 M1 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 MDS-UPDRS = Movement Disorder Society-Unified Parkinson's
Disease Rating Scale2 Source:
https://www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia3
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: NCT04575259
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Apr 2024 to May 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From May 2023 to May 2024