Anavex Life Sciences to Initiate Phase 2 Study of ANAVEX®2-73 in Parkinson’s Disease Dementia and Provides Clinical Study ...
April 17 2018 - 07:08AM
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, Parkinson’s disease, Rett syndrome and other
central nervous system (CNS) diseases, today announced that the
Company is planning to initiate a Phase 2 clinical trial of lead
candidate ANAVEX®2-73 in Parkinson’s Disease Dementia (PDD).
“As many as 80 percent of people with
Parkinson’s will experience Parkinson’s disease dementia and
treatment options are limited,” said Christopher U Missling, PhD,
President and Chief Executive Officer of Anavex. “We are excited to
progress our program to Phase 2, with a focus on the many patients
with Parkinson’s disease dementia, and we remain focused on the
discovery and development of potential treatments for neurological
diseases with unmet needs, including Alzheimer’s disease and Rett
syndrome.”
There is a significant unmet medical need in the
development of Parkinson’s disease therapies that could be
addressed by Anavex’s novel, sigma-1 receptor agonist, ANAVEX®2-73,
in Parkinson’s disease patients with dementia, or PDD. The Company
is moving forward with a Phase 2 trial with ANAVEX®2-73 in PDD,
which will study the effect of the compound on both the cognitive
and motor impairment of Parkinson’s disease. The double-blind,
randomized, placebo-controlled Phase 2 PDD study has been submitted
to regulatory authorities in Europe, and pending approval, the
Company plans to initiate this clinical trial H2 2018. Additional
protocol details will be shared at that point.
The earlier studies of ANAVEX®2-73 in a disease
modifying model of Parkinson’s disease were funded by The Michael
J. Fox Foundation for Parkinson’s Research.
In addition, an updated investigational new drug
application (IND) for the double-blind, randomized,
placebo-controlled ANAVEX®2-73 Phase 2 study in Rett syndrome was
submitted to the FDA in the first quarter of 2018. The Company is
currently in dialogue with the agency and anticipates potential
initiation of this clinical trial H2 2018. Additional protocol
details will be shared at that point.
About Parkinson’s disease with 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 50 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.1
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, 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 to develop
ANAVEX®2-73 for the treatment of Parkinson’s disease. The grant
fully funded a preclinical study, which could justify moving
ANAVEX®2-73 into a Parkinson’s disease clinical trial. 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.
1 Source:
www.alz.org/dementia/parkinsons-disease-symptoms
For Further Information:
Anavex Life Sciences Corp. Research & Business Development
Toll-free: 1-844-689-3939 Email: info@anavex.com
Investors & Media:Clayton Robertson The Trout Group (646)
378-2900 crobertson@troutgroup.com
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