Late-Breaking Data Demonstrate Significant
Association Between Higher ANAVEX®2-73 Concentration and Maintained
Activities of Daily Living and Reduced Cognitive Decline in
Alzheimer’s Disease Patients
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 diseases including Alzheimer’s disease, Rett
syndrome and other central nervous system (CNS) diseases, today
presented new clinical data for ANAVEX®2-73 in a late-breaking oral
presentation at the 2018 Clinical Trials on Alzheimer’s Disease
(CTAD) Meeting.
At 148 weeks into the five-year extended Phase
2a clinical study of ANAVEX®2-73, data confirmed a significant
association between ANAVEX®2-73 concentration and both exploratory
functional and cognitive endpoints as measured by the Alzheimer’s
Disease Cooperative Study-Activities of Daily
Living (ADCS-ADL) evaluation and the Mini Mental State
Examination (MMSE), respectively. The cohort of patients treated
with higher ANAVEX®2-73 concentration maintained ADCS-ADL
performance compared to the lower concentration cohort
(p<0.0001). The patient cohort with the higher ANAVEX®2-73
concentration performed better at MMSE compared to the lower
concentration cohort (p<0.0008).
A significant impact on the drug response levels
of both the SIGMAR1 (p<0.0080) and COMT (p<0.0014) genomic
biomarkers, identified and specified at week 57, was also confirmed
over the 148-week period.
ANAVEX®2-73 demonstrated
continued favorable safety and tolerability through 148 weeks.
“These results further confirm the impact of
actionable genetic variants that were previously identified through
a full, unbiased genomic analysis of ANAVEX®2-73 in Alzheimer’s
disease, raising optimism for the future of biomarker-guided
precision medicine to effectively combat this devastating disease,”
said Professor Harald Hampel, M.D., Ph.D., M.A., M.Sc., AXA
Research Fund & Sorbonne University Excellence Chair,
Departments of Neuroscience and Neurology, Sorbonne University,
Paris, France. Professor Hampel is the president of the Alzheimer
Precision Medicine Initiative (APMI).
“We are excited to see our initial biomarker
hypothesis confirmed at 148 weeks. The biomarkers were selected
through a systematic, data-driven analysis of all available genomic
and clinical data, which identified a genomic alteration of
SIGMAR1, the target of ANAVEX®2-73. The consistency of the DNA and
RNA data, as well as multiple endpoints and time-points further
strengthen this biomarker hypothesis,” said Mohammad Afshar, M.D.,
Ph.D., CEO of Ariana Pharma. “This innovative data analytics
approach, using our KEM® Artificial Intelligence platform has the
potential to expand the access to precision medicine and precision
pharmacology for a wide range of neurodegenerative diseases, thus,
identifying the right patients that can benefit from the right
therapy, at the right moment.”
“We are encouraged by these data which now show
the clinical impact of ANAVEX®2-73 on patients who have been
receiving therapy for almost three years,” said Christopher U.
Missling, Ph.D., President and Chief Executive Officer of Anavex.
“We continue to build on the body of clinical evidence to support
the development of ANAVEX®2-73 as we further our recently initiated
Phase 2b/3 study, and we will continue our targeted precision
medicine approach to advance ANAVEX®2-73 as a potential therapeutic
option for patients with Alzheimer’s disease who will most benefit
from treatment.”
Presentation Details:
Title: Longitudinal 148-Week
Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease
Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL)
and Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher
Drug Concentration and Confirms Role of Patient Selection
Biomarkers1
The slides are accessible through the investor
relations section of the Company's website at www.anavex.com.
________________________
1 Harald Hampel1, Mohammad Afshar2, Frédéric
Parmentier2, Coralie Williams2, Adrien Etcheto2, Federico
Goodsaid3, Christopher U. Missling4; (1) Department of Neurology,
Sorbonne University, Paris, France; (2) Ariana Pharma, Paris,
France; (3) Regulatory Pathfinders LLC, San Francisco, CA; (4)
Anavex Life Sciences Corp., New York, NY
About ANAVEX®2-73-002 Phase 2a Clinical
Study (ClinicalTrials.gov NCT02244541)
The multi-center Phase 2a clinical trial of
ANAVEX®2-73 consisted of two parts and a total of 32
mild-to-moderate Alzheimer’s patients. PART A was a randomized,
open-label, two-period, cross-over between oral (30mg/50mg) and IV
(3mg/5mg) administration, adaptive trial lasting up to five weeks
for each patient. PART B was an open-label extension for an
additional 52 weeks. Initially planned for 26 weeks, PART B was
extended to 52 weeks as a result of requests from patients and
caregivers.
The primary endpoints of the Phase 2a trial were
safety, tolerability and maximum tolerated dose (MTD) of
ANAVEX®2-73, which had shown potential in preclinical studies to
prevent, halt and/or reverse the course of the disease. Secondary
endpoints included dose response, bioavailability, and exploratory
cognitive and functional measures using the Mini Mental State
Examination (MMSE) and evaluation of Alzheimer’s Disease
Co-operative Study – Activities of Daily Living Inventory
(ADCS-ADL), as well as Cogstate test battery and biomarker
EEG/ERP.
About ANAVEX®2-73-003 Phase 2a Clinical
Study (ClinicalTrials.gov NCT02756858)
The multi-center Phase 2a clinical trial of
ANAVEX®2-73 consists of an open-label extension for an additional
208 weeks, allowing for the collection of potential safety data for
ANAVEX®2-73 cumulatively over five years. The 208-week (four-year)
extension of the multi-center Phase 2a clinical trial of
ANAVEX®2-73 will follow mild-to-moderate Alzheimer’s patients who
have already completed 52 weeks in PART B of the study. Every three
months, patients will be scheduled for physician visits to assess
primary and secondary endpoints.
The primary endpoints of the new Phase 2a trial
are safety and tolerability of ANAVEX®2-73. Secondary
endpoints are exploratory cognitive and functional measures using
the Mini Mental State Examination (MMSE) and evaluation of
Alzheimer’s Disease Co-operative Study – Activities of Daily Living
Inventory (ADCS-ADL), respectively.
About the Alzheimer’s Disease Precision
Medicine Initiative (APMI)
The Alzheimer’s Disease Precision Medicine
Initiative (APMI), established in 2016 by founding president
Professor Harald Hampel of Sorbonne University, Paris, France, is
an international interdisciplinary consortium of leading
neuroscientists aimed to facilitate breakthrough reforms towards
early detection and successful drug development of neurological
diseases, such as Alzheimer’s disease, away from a traditional
“one-size fits all” approach to drug development of biologically
heterogeneous populations towards individualized biomarker-guided
targeted therapy for the right patient at the right time. Further
information is available at www.apmiscience.com.
About Ariana Pharma
Ariana Pharma is a leading digital health
Company focused on developing advanced therapeutic decision support
systems. Ariana’s innovative clinical data analysis and diagnostic
testing solutions help the healthcare sector better adapt patient
treatments to individual biological characteristics. Ariana KEM®
Artificial Intelligence technology enables personalization of
therapies, improves the efficacy and safety of patient treatment,
reduces risks and drug development costs, and accelerates time to
market. With a growing number of successful therapeutic development
applications, KEM® is the only FDA-reviewed technology that
systematically explores combinations of biomarkers, producing more
effective biomarker signatures for precision medicine. Ariana has
developed Onco KEM®, the most advanced, clinically tested, oncology
treatment selection system. Founded in 2003 as a spin-off of the
Institut Pasteur, Paris, France, the company opened a subsidiary in
the United States in 2012. Further information is available at
www.arianapharma.com.
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 diseases including
Alzheimer’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, recently completed a successful Phase
2a clinical trial for Alzheimer’s disease. 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 M1 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
neuroinflammation and mitochondrial dysfunction. 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:
Scott GordonCore IRscottg@coreir.com
Media:
Melyssa WeibleElixir Health Public
Relations201-723-5805mweible@elixirhealthpr.com
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