Anavex Life Sciences Provides Supplemental Information on ANAVEX®2-73 (Blarcamesine) AVATAR Phase 3 Trial for the Treatment of Adult Patients with Rett Syndrome
February 04 2022 - 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 provides supplemental information on the
ANAVEX®2-73 (blarcamesine) AVATAR Phase 3 trial for the treatment
of adult patients with Rett syndrome.
Following the successful completion of U.S.
Phase 2 Rett syndrome study (ANAVEX®2-73-RS-001) as announced in
December 2020, and the knowledge gained from it, the AVATAR study
(ANAVEX®2-73-RS-002) appropriately updated endpoints according to
ICH guidelines were approved by the U.K. Medicines and Healthcare
products Regulatory Agency (MHRA) and in Australia by the Human
Research Ethics Committees (HREC), where the AVATAR study was
conducted. Subsequently the AVATAR study was updated from a Phase 2
to a Phase 3 study. The January 2022 update to the trial
description in ‘clinicaltrials.gov’ was not a real-time
communication and may have given the wrong impression of a late
change of trial endpoints / phase of the study, which is not the
case.
Based on the results of the AVATAR Phase 3 study
(ANAVEX®2-73-RS-002) and the prior successful U.S. Phase 2
(ANAVEX®2-73-RS-001) study in adult patients with Rett syndrome,
Anavex is planning to meet with the FDA to discuss the approval
pathway. There are no FDA-approved drugs for Rett syndrome.
ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease
designation and Orphan Drug designation from the FDA for the
treatment of Rett syndrome.
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),
successfully completed a Phase 2a clinical trial for Alzheimer’s
disease and recently a Phase 2 proof-of-concept study in
Parkinson’s disease dementia and a Phase 2 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
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 RelationsTel: 516-662-9461Email:
andrew@barwicki.com
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Anavex Life Sciences (NASDAQ:AVXL)
Historical Stock Chart
From Apr 2023 to Apr 2024