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 disorders announced today that
representatives of Anavex met with team members of the European
Medicines Agency (EMA).
These meetings discussed the debilitating
pathology of Alzheimer’s disease and Anavex’s blarcamesine
(ANAVEX®2-73) Alzheimer’s disease clinical program results,
including data obtained in the ANAVEX®2-73-AD-004 study.
Pursuant to discussion at the meetings, Anavex
initiated the process for submitting a Marketing Authorisation
application to the EMA with the submission of the Centralised
Procedure request with the goal of the Authorisation allowing
direct access to the market of the European Union for oral
blarcamesine for the treatment of Alzheimer’s disease.
Anavex’s goal is to take care of patients in a
patient-centric way with the preference for convenient oral
treatment options for Alzheimer’s disease not requiring complex
logistics resources and added personnel for drug administration and
monitoring for brain edema and brain bleeds.
Severe symptoms in relation to Amyloid-Related
Imaging Abnormalities (ARIA) is a known risk factor for Alzheimer’s
patients taking the class of drugs called monoclonal antibodies,
and requires constant and repeated MRI examination, for which not
all regions in Europe are currently sufficiently prepared and
equipped for in addition to the requirement to address
affordability and inequalities in patient access within European
Union countries.1,2
“We look forward to working together with the
team from EMA,” said David Goldberger, RPh, MLS, Senior Vice
President Regulatory Affairs at Anavex. “We continue to work
towards fulfilling our purpose of improving patients' lives with
oral blarcamesine not requiring any complex additional procedures
for the treatment of people with Alzheimer’s disease.”
There are an estimated 7 million people in
Europe with Alzheimer’s disease, a number expected to double by
2030, according to the European Brain Council.3
The World Health Organization (WHO) estimated
the cost in Europe of caring for people with dementia, including
Alzheimer's disease, at $439 billion, or $31,144 per person in
2019. That includes hospital care, medicines, diagnostics, informal
caregiver time, community services and long-term care facility
costs.4,5
“There remains an urgent need for convenient
once-daily oral treatment options for Alzheimer’s disease, and
Anavex is moving forward to potentially addressing the preference
for simple patient-centered administrations and shared
decision-making,” said Christopher U Missling, PhD, President and
Chief Executive Officer at Anavex.
In addition to significant improvement in
dementia symptoms, blarcamesine demonstrated reduction of
pathological aggregation of amyloid in early Alzheimer’s disease as
well reduction of brain volume loss, a well-known marker of
neurodegeneration.
Data from the blarcamesine in Alzheimer’s
disease Phase 2b/3 randomized clinical trial will be published in
an upcoming peer-reviewed journal.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a
publicly traded biopharmaceutical company dedicated to the
development of novel therapeutics for the treatment of
neurodegenerative and neurodevelopmental disorders, including
Alzheimer's disease, Parkinson'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 (blarcamesine),
has successfully completed a Phase 2a and a Phase 2b/3 clinical
trial for Alzheimer's disease, a Phase 2 proof-of-concept study in
Parkinson's disease dementia, and both a Phase 2 and a Phase 3
study in adult patients with Rett syndrome. 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 clinical stage
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
mitochondrial dysfunction and neuroinflammation. Further
information is available at www.anavex.com. You can also connect
with the Company on Twitter, Facebook, Instagram, 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:Andrew J.
BarwickiInvestor Relations
Tel: 516-662-9461Email: andrew@barwicki.com
1 Frölich L, Jessen F. Editorial: Lecanemab:
Appropriate Use Recommendations - A Commentary from a European
Perspective. J Prev Alzheimers Dis. 2023;10(3):357-358. doi:
10.14283/jpad.2023.44. PMID: 37357274.2 Jönsson L, Wimo A, Handels
R, Johansson G, Boada M, Engelborghs S, Frölich L, Jessen F, Kehoe
PG, Kramberger M, de Mendonςa A, Ousset PJ, Scarmeas N, Visser PJ,
Waldemar G, Winblad B. The affordability of lecanemab, an
amyloid-targeting therapy for Alzheimer's disease: an EADC-EC
viewpoint. Lancet Reg Health Eur. 2023 May 22;29:100657. doi:
10.1016/j.lanepe.2023.100657. PMID: 37251789; PMCID: PMC10220264.3
https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/4
Jönsson L. The personal economic burden of dementia in Europe.
Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi:
10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307.5
World Health Organization (WHO); 2021. Global status report on the
public health response to dementia.
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