Anavex Life Sciences Provides Update on Clinical Program Development as Response to COVID-19
March 31 2020 - 7:00AM
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 including Alzheimer’s disease,
Parkinson’s disease, Rett syndrome and other central nervous system
(CNS) diseases, today provided an update on the evolving COVID-19
condition and the Company’s response to its clinical program
development.
Anavex’s paramount obligation is to ensure the
safety of all participants in its clinical programs and the
integrity of the studies in which they participate. Anavex is
responding to regulatory, institutional, and government guidance
and policies related to COVID-19. Anavex remains committed to its
clinical development plans and is working closely with all
stakeholders to try to mitigate the effect of COVID-19 on the
Company’s ongoing clinical trials for Rett syndrome, Parkinson’s
disease dementia and Alzheimer’s disease.
Clinical sites continue to operate and see
patients where possible in accordance with local regulations and
site policies, regulatory, institutional, and government guidance
related to COVID-19. Clinical sites continue to screen and enroll
patients into the active trials and the respective open-label
extensions for the two Phase 2 Rett syndrome trials and the Phase
2b/3 Alzheimer’s disease trial, while the Parkinson’s disease
dementia Phase 2 trial has completed enrollment and we expect to
announce topline results from this study by mid-2020.
Anavex pro-actively continues to bring on sites
in new countries across programs depending on the situation in each
country of operations. While Rett syndrome protocols
ANAVEX2-73-RS-001 and ANAVEX2-73-RS-002 have always by default
allowed at-home visits, U.S. FDA and European EMA and Australian
TGA recommended contingency plans are actively in place for the
Alzheimer’s disease Phase 2b/3 study ANAVEX2-73-AD-004 and the
Parkinson’s disease dementia Phase 2 study ANAVEX2-73-PDD-001 to
ensure remote or virtual assessments for active patients and all
respective extension studies.
Because ANAVEX2-73 is an oral formulation, study
participants are able to receive shipments of their study
medication in a controlled and compliant fashion, and
direct-to-patient delivery is occurring in multiple countries.
“We understand that some activities will be
temporarily slower because of COVID-19, however, our
risk-mitigation actions were implemented for every project and
Anavex’s primary focus is on the safety of all involved and the
continued conduct of our clinical programs as we navigate the
pandemic together”, said Christopher U Missling, PhD. “Our sites
understand why their patients participate in research and are
committed to the importance of clinical trials for those patient
communities currently without effective treatments.”
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 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),
recently completed a successful Phase 2a clinical trial for
Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s
disease. ANAVEX®3-71, which targets sigma-1 and 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 mitochondrial
dysfunction and neuroinflammation. 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.
For Further Information:
Anavex Life Sciences Corp.Research &
Business DevelopmentToll-free:
1-844-689-3939Email: info@anavex.com
Investors & Media:Email:
ir@anavex.com
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