Anavex Life Sciences Announces 12-Month Data of ANAVEX 2-73 in a Phase 2a Study in Mild-to-Moderate Alzheimer’s Disease Pat...
December 08 2016 - 7:00AM
Data presentation at CTAD
2016
Anavex Life Sciences Corp. (“Anavex” or the “Company”)
(Nasdaq:AVXL) today announced a positive 57-week update from its
Phase 2a study in mild-to-moderate Alzheimer’s disease (AD)
patients for ANAVEX 2-73, which targets cellular homeostasis. The
study met both primary and secondary endpoints.
At 57 weeks, Alzheimer’s patients taking a daily
oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated.
There were no clinically significant treatment-related adverse
events and no serious adverse events.
Published AD studies confirmed substantial
declines of cognitive (MMSE) and functional (ADCS-ADL) measures as
well as Cogstate and EEG/ERP over 12 month in similar AD
populations. Pre-specified exploratory analyses of the current
study included the cognitive (MMSE) and the functional (ADCS-ADL)
as well as Cogstate, HAM-D and EEG/ERP changes from baseline.
Specifically, in comparison to historical
control from a pooled placebo arm cohort study conducted by the
Alzheimer Disease Cooperative Study Group in mild-to-moderate AD
patients of comparable ages and MMSE baselines, over 12 month the
ANAVEX 2-73 data shows a calculated treatment benefit of 1.8 points
on the MMSE scale (p<0.016) and a calculated treatment benefit
of 4 points on the ADCS-ADL score (p<0.019). Furthermore, the
correlation was positive with all measured scores (MMSE, ADCS-ADL,
Cogstate, HAM-D and EEG/ERP).
George Perry, PhD, Dean and Professor at the
University of Texas at San Antonio and Editor-in Chief of the
Journal of Alzheimer’s Disease, commented, “In addition to the very
encouraging results, which point to the therapeutic potential of
targeting cellular homeostasis in a complex CNS disease like
Alzheimer’s, this trial has been intelligently designed as a highly
informative study, looking unprejudiced at all potential
relationships and hence allowing to learn from all correlations of
the now available pool of data, in order to execute subsequent
trials with much more relevant information at hand.”
Despite non-optimized dosing of ANAVEX 2-73
throughout the 12-month study, continued significant improvements
from baseline of cognitive, functional and behavioral scores in a
group of patients were observed, respectively. This data will be
analyzed using refined mathematical modeling methods in conjunction
with the detailed pharmacokinetic (PK) information.
“Alzheimer’s disease is a progressive
neurodegenerative disease that causes problems with memory,
thinking and behavior. Currently available treatments cannot stop
Alzheimer's from progressing; they can only temporarily slow the
worsening of dementia symptoms,” said Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. "We believe this
data gives us a solid foundation from which to continue the next
phase of rationally designed clinical trials. Anavex is grateful
for the dedication of the patients, their families and the clinical
investigators who participated in this study."
The Company is presenting findings from the
study at the Clinical Trials on Alzheimer's Disease (CTAD) meeting
on Saturday, December 10th at 8:45 a.m. PT in the oral
communication session. The presentation will be available in the
publications section of the Anavex website.
The Company will also conduct a conference call
with the investment community in conjunction with the upcoming
financial year-end 2016 report.
About the ANAVEX 2-73 Phase 2a
Study The multicenter Phase 2a clinical trial of
ANAVEX 2-73 consists of two parts and a total of 32
mild-to-moderate Alzheimer’s patients. PART A is a simple
randomized, open-label, two-period, cross-over between oral
(30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting
up to 5 weeks for each patient. PART B is 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 endpoint of the Phase 2a trial is to
establish 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 include dose response, bioavailability, and exploratory
cognitive as well as functional measures using 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 EEG/ERP.
Additional information regarding the ongoing
Phase 2a clinical trial is available from the U.S. National
Institutes of Health (NIH) clinical trials database at
www.clinicaltrials.gov.
About CTAD 2016The
International Conference on Clinical Trials for Alzheimer’s Disease
(CTAD) is an annual conference organized and planned by Alzheimer’s
disease clinical researchers to share scientific information with
each other. The 9th annual CTAD 2016 will be held December 8-10 in
San Diego, CA. Further information is available at
http://www.ctad-alzheimer.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, other central nervous system (CNS) diseases,
pain and various types of cancer. Anavex’s lead drug candidate,
ANAVEX 2-73, is currently in a 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 and successfully completed Phase 1 with a
clean safety profile. Preclinical studies demonstrated its
potential to halt and/or reverse the course of Alzheimer’s disease.
It has also exhibited anticonvulsant, anti-amnesic, neuroprotective
and anti-depressant properties in animal models, indicating its
potential to treat additional CNS disorders, including epilepsy and
others. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic
receptors, is a promising preclinical drug candidate demonstrating
disease modifications against the major Alzheimer’s hallmarks in
transgenic (3xTg-AD) mice, including cognitive deficits, amyloid
and tau pathologies, and also with beneficial effects on
neuroinflammation and mitochondrial dysfunctions. Further
information is available at www.anavex.com.
Forward-Looking
StatementsStatements 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 Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matthew Haines
River East Investor Relations, LLC
(917) 733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
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