Anavex Life Sciences Announces Data on 41-Week Treatment of ANAVEX 2-73 for Patients with Alzheimer’s Disease − Investiga...
November 22 2016 - 6:00AM
Anavex Life Sciences Corp. (“Anavex” or the “Company”)
(Nasdaq:AVXL) today announced a positive 41-week update from its
Phase 2a study in mild-to-moderate Alzheimer’s disease (AD)
patients for ANAVEX 2-73, which targets cellular homeostasis.
At 41 weeks, Alzheimer’s patients taking a daily
oral dose of ANAVEX 2-73 in the exploratory, not yet dose optimized
Phase 2a clinical trial, showed a stabilization of cognitive and
functional measures. This data of stabilization is promising since
Alzheimer’s disease is a progressive disease where current
therapeutics are only able to temporarily slow the worsening of
dementia symptoms and not stop the disease from progressing.
At 41 weeks, oral daily dosing between 10mg and
50mg, ANAVEX 2-73 was well tolerated, and no patients discontinued
treatment due to adverse events. There were no clinically
significant treatment-related adverse events, and no serious
adverse events.
Pre-specified exploratory analyses included the
cognitive (MMSE) and the functional (ADCS-ADL) changes from
baseline. A continued stabilization of both cognitive (MMSE) and
functional (ADCS-ADL) measures in patients treated with ANAVEX 2-73
was observed. This 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, “Although this is an
open label study with 32 patients, I have never seen
mild-to-moderate Alzheimer’s patients maintain near baseline
cognitive and activities of daily living function and positive
correlation with all other measures over a 41-week trial period in
any prior study with an approved or experimental drug. It is quite
plausible that complex CNS diseases like Alzheimer’s may require a
comprehensive approach, including restoration of cellular
homeostasis.”
Published Alzheimer disease studies confirm
substantial declines of both the cognitive (MMSE) and the
functional (ADCS-ADL) measures over this timeframe in a similar AD
population. 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 nine months the ANAVEX
2-73 data shows a potential treatment benefit of several points on
both the MMSE scale and on the ADCS-ADL score.
"We are encouraged, however, we should be
reminded that these endpoints are exploratory and need to be
confirmed in a larger study, for which planning is underway," said
Christopher U. Missling, PhD, President and Chief Executive Officer
of Anavex. "This data provides valuable safety, tolerability and
behavioral information for ANAVEX 2-73, which might allow us to
also target shorter-term endpoints including behavioral and
psychological symptoms."
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 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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