Anavex Life Sciences Announces Full Enrollment of Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia
May 01 2025 - 7:30AM
Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq:
AVXL), a clinical-stage biopharmaceutical company focused on
developing innovative treatments for Alzheimer's disease,
Parkinson's disease, schizophrenia, neurodevelopmental,
neurodegenerative, and rare diseases, including Rett syndrome, and
other central nervous system (CNS) disorders, today announced the
successful completion of enrollment in its Phase 2 clinical study
of ANAVEX®3-71 for the treatment of schizophrenia
(ANAVEX3-71-SZ-001, NCT06245213).
The study has enrolled a total of 71
participants, with 16 participants in Part A and 55 participants in
Part B. Part A of the study, which investigated multiple ascending
doses, has been completed with encouraging preliminary safety and
electroencephalography (EEG) biomarker results previously reported.
Part B, which includes more participants and a longer treatment
duration, will provide more comprehensive clinical and biomarker
data on the efficacy and safety of ANAVEX®3-71 in individuals with
schizophrenia.
“We are pleased to announce the full enrollment
of our ANAVEX3-71-SZ-001 study and would like to thank all the
patients and investigators for their participation in this first
clinical efficacy trial of ANAVEX®3-71,” said Christopher U
Missling, PhD, President and Chief Executive Officer of Anavex.
“There is a substantial unmet medical need for a drug that can
effectively address all symptoms of schizophrenia, and we are
hopeful that these results are encouraging for further development
of ANAVEX®3-71 for people with schizophrenia.”
Oral ANAVEX®3-71 is a dual SIGMAR1 receptor
agonist and M1 positive allosteric modulator with agonistic
effects. This novel mechanism of action offers the potential to
treat all symptom domains of schizophrenia without the side effects
of standard of care antipsychotics.
The Company expects to report top-line data from
the study in the second half of 2025.
This release discusses investigational uses of
an agent in development and is not intended to convey conclusions
about efficacy or safety. There is no guarantee that any
investigational uses of such product will successfully complete
clinical development or gain health authority approval.
About Schizophrenia
Schizophrenia is a persistent and often
disabling mental illness impacting how a person thinks, feels, and
behaves, and affects nearly 24 million people worldwide, including
2.8 million people in the U.S. It is characterized by three symptom
domains: positive symptoms (hallucinations and delusions), negative
symptoms (difficulty enjoying life and withdrawal from others), and
cognitive impairment (deficits in memory, concentration, and
decision-making). In part due to limitations with current
treatments, people living with schizophrenia often struggle to
maintain employment, live independently, and manage relationships.
While current treatments can be effective in managing select
symptoms, approximately 34% of people do not respond to therapy, 1
with an additional 50-60% experiencing only a partial improvement
in symptoms or unacceptable side effects.2
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, neurodevelopmental, and neuropsychiatric
disorders, including Alzheimer's disease, Parkinson's disease,
schizophrenia, 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 and one Phase 2/3 study in pediatric
patients with Rett syndrome. ANAVEX®2-73 is an orally available
drug candidate designed to restore cellular homeostasis by
targeting SIGMAR1 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. We believe that ANAVEX®3-71,
which targets SIGMAR1 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 RelationsTel: 516-662-9461Email:
andrew@barwicki.com
1 Potkin SG, Kane JM, Correll CU, et al. The neurobiology of
treatment-resistant schizophrenia: paths to antipsychotic
resistance and a roadmap for future research. NPJ Schizophr.
2020;6(1):1. Published 2020 Jan 7. doi:10.1038/s41537-019-0090-z2
Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment
resistant schizophrenia: Clinical, biological, and therapeutic
perspectives. Neurobiol Dis. 2019;131:104257.
doi:10.1016/j.nbd.2018.08.016
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