Anavex Life Sciences announces acceptance of a manuscript on blarcamesine for early Alzheimer's disease, expected publication in late 2024.
Quiver AI Summary
Anavex Life Sciences Corp. announced the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease” based on results from their ANAVEX2-73-AD-004 Phase IIB/III trial, with publication expected in late 2024 or early 2025. This milestone underscores the significance of Anavex’s research for the Alzheimer's community, as highlighted by the company's leadership. Anavex is preparing to submit their oral drug candidate, blarcamesine, for regulatory approval in Europe in the current quarter of 2024. The company is dedicated to developing therapeutics for various neurological conditions and has reported promising results from several clinical trials for blarcamesine, which targets cellular mechanisms associated with Alzheimer’s disease and has shown potential in treating other CNS disorders.
Potential Positives
- Acceptance of a peer-reviewed manuscript on the efficacy of Blarcamesine for Early Alzheimer’s Disease highlights the scientific validation of the company's research efforts.
- The expected regulatory submission of oral Blarcamesine in Europe within the current quarter signifies progress toward potential market entry for treatment of a widespread disease.
- This press release strengthens Anavex's visibility within the medical community and enhances its credibility as a developer of innovative CNS therapies.
Potential Negatives
- The press release emphasizes that the company’s investigational product is not guaranteed to successfully complete clinical development or gain health authority approval, indicating potential risks associated with their lead drug candidate.
- There is no definitive conclusion established regarding the efficacy or safety of the drug, which may raise concerns among investors and stakeholders about the viability of the treatment.
- Risk factors mentioned could lead to skepticism regarding the future prospects of Anavex and could impact investor confidence negatively.
FAQ
What is Blarcamesine's role in Alzheimer's disease treatment?
Blarcamesine is Anavex's lead drug candidate aimed at treating Alzheimer's disease by restoring cellular balance.
When will the peer-reviewed manuscript be published?
The manuscript is expected to be published around Q4 2024 or Q1 2025 in a medical journal focused on Alzheimer's disease.
What clinical trials has ANAVEX®2-73 completed?
ANAVEX®2-73 has completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease.
How prevalent is Alzheimer's disease in Europe?
There are approximately 7 million people with Alzheimer's disease in Europe, with numbers expected to double by 2030.
What are the potential benefits of ANAVEX®3-71?
ANAVEX®3-71 shows promise in targeting Alzheimer’s hallmarks, improving mitochondrial dysfunction, and reducing neuroinflammation.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$AVXL Insider Trading Activity
$AVXL insiders have traded $AVXL stock on the open market 1 times in the past 6 months. Of those trades, 1 have been purchases and 0 have been sales.
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- PETER D.O. DONHAUSER purchased 2,835 shares.
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Full Release
NEW YORK, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced the acceptance of a peer-reviewed manuscript titled, “ Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial ,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025.
“The publication in a peer-reviewed medical journal is an important milestone for the Anavex team and is a testament to the importance of the findings for the scientific and Alzheimer’s disease communities,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “We are on track for regulatory submission of oral blarcamesine in Europe (EMA) in the current quarter 2024.”
“We are honored to be sharing this peer-reviewed manuscript in an international journal,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide and this forthcoming publication could be helpful to educate the medical and scientific community about the potential of oral blarcamesine for patients with Alzheimer's disease.”
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 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. 1 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. 2 , 3
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 Development
Toll-free: 1-844-689-3939
Email:
[email protected]
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email:
[email protected]
1
https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/
2
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.
3
World Health Organization (WHO); 2021. Global status report on the public health response to dementia.