Anavex Presents 31-Week Safety Data from Phase 2a Study of ANAVEX 2-73 in Alzheimer’s Patients at AAIC 2016
July 24 2016 - 9:30AM
Results Feature Favorable Safety, Maximum
Tolerated Dose, Positive Dose Response as well as Positive
Unexpected Therapeutic Response Events
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, other central nervous system (CNS) diseases,
pain and various types of cancer, today announced data from the
first of two posters at the Alzheimer’s Association International
Conference® (AAIC) 2016.
Data presented in the first poster highlights
the evaluation of a maximum tolerated dose (MTD) of ANAVEX 2-73 as
primary endpoint of the Phase 2a study in mild-to-moderate
Alzheimer’s patients, as well as additional clinical safety data
and positive unexpected therapeutic response events, such as
improved mood, improved social engagement and increased independent
activities through 31 weeks. The second poster will present
efficacy data through 31 weeks.
“ANAVEX 2-73 data presented today is
prerequisite information in order to progress into Phase 2/3
placebo controlled studies,” said Professor Harald Hampel, MD, PhD,
Professor and AXA Research Fund Chair at Sorbonne Universities’
Pierre and Marie Curie University (UPMC), Paris, France and member
of Anavex’s Scientific Advisory Board. “ANAVEX 2-73’s specific
molecular biology, combined with its observed favorable safety and
tolerability profile makes it a very interesting candidate to
explore in further clinical trials of different neurological
diseases.”
Dose-response analysis indicates a cognitive
benefit associated with ANAVEX 2-73 (both MMSE and EEG/ERP improved
significantly at 5 weeks of treatment). Low-High dose was
statistically significant to affect MMSE-Δ and ERP-Δ scores with
MMSE-Δ (p=0.0285) and ERP-Δ (p=0.0168), respectively.
ANAVEX 2-73 continues to demonstrate a favorable
adverse event (AE) profile through 31 weeks in a patient population
of elderly Alzheimer’s patients with varying degrees of physical
fragility. The most common side effects across all AE categories
tended to be of mild severity grade 1, and were resolved with dose
reductions that were anticipated within the adaptive design of the
study protocol. The poster presentation is available on the
publications page of the Anavex website.
“We are encouraged by these new results, which
provide us with valuable knowledge about ANAVEX 2-73 and allow us
to proceed methodically in the development of ANAVEX 2-73,” said
Christopher U. Missling, PhD, President and Chief Executive Officer
of Anavex.
About the ANAVEX 2-73 Phase 2a
Study
The multi-center Phase 2a clinical trial of 32
mild-to-moderate Alzheimer’s patients consists of two parts. In
PART A ANAVEX 2-73 is administered during five weeks in a
randomized, open-label study with adaptive design. PART B is
continued administration of ANAVEX 2-73 in a voluntary 52-week
open-label extension, followed by an additional voluntary 104-week
extension study, allowing for the gathering of safety data for
ANAVEX 2-73 cumulatively over three years.
The primary endpoint of the Phase 2a trial is to
establish safety, tolerability and maximum tolerated dose (MTD) of
ANAVEX 2-73. Secondary endpoints includes 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), respectively.
Additional information regarding the ongoing
Phase 2a clinical study 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 targets 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. The
Michael J. Fox Foundation (MJFF) for Parkinson’s Research has
awarded Anavex a research grant to develop ANAVEX 2-73 for the
treatment of Parkinson’s disease to fully fund a preclinical study,
which could justify moving ANAVEX 2-73 into a Parkinson’s disease
clinical trial. 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 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 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:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
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