Anavex Life Sciences Announces Late-Breaking Presentation of Phase 2b/3 Data of Oral ANAVEX®2-73 (blarcamesine) for Early Alzheimer’s Disease at the Upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) announced the presentation of Phase 2b/3 data for ANAVEX®2-73 (blarcamesine) aimed at treating Early Alzheimer's Disease, scheduled for December 1, 2022, at the CTAD Congress in San Francisco. A/Prof. Stephen Macfarlane will present the findings, which will also be published in a peer-reviewed journal. ANAVEX®2-73 is recognized as a significant therapeutic option targeting the sigma-1 receptor, showing promise from prior clinical trials in Alzheimer's and other CNS disorders. The economic burden of Alzheimer's is projected to exceed $1 trillion as the population ages.

Positive

• ANAVEX®2-73 successfully completed Phase 2a trials for Alzheimer's and Phase 2 trials for Parkinson's disease dementia and Rett syndrome.
• The upcoming presentation at CTAD Congress highlights the company's commitment to advancing Alzheimer's treatment research.

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• None.

NEW YORK, Oct. 17, 2022 (GLOBE NEWSWIRE) -- 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) disorders, today announced that the company will present Phase 2b/3 ANAVEX®2-73-AD-004 data of oral ANAVEX®2-73 (blarcamesine) for Early Alzheimer’s Disease at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) Congress 2022 in San Francisco, CA and publish the findings in a peer-reviewed medical journal.

Top Line Data of ANAVEX®2-73 (blarcamesine) Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2b/3 in Patients with Early Alzheimer’s Disease (AD)
Date / Time: December 1, 2022 / 4:30pm PT
Presenter: A/Prof. Stephen Macfarlane, Principal Investigator
Session Title: LB8 - LATE BREAKING ORAL COMMUNICATIONS

ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1), which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.¹

Prior to the completion of the larger Phase 2b/3 study ANAVEX®2-73-AD-004 (NCT03790709) for the treatment of Early Alzheimer’s Disease, using precision medicine included SIGMAR1 biomarker of response, ANAVEX®2-73 (blarcamesine) successfully completed a randomized, double-blind, multicenter, placebo-controlled Phase 2 in Parkinson’s disease dementia and a Phase 2a clinical trial for Alzheimer’s disease. In addition, ANAVEX®2-73 (blarcamesine) successfully completed a randomized, double-blind, multicenter, placebo-controlled Phase 2 in adult Rett syndrome and a randomized, double-blind, multicenter, placebo-controlled Phase 3 in adult Rett syndrome, respectively.

Economic Burden of Alzheimer's Disease²

Alzheimer's disease is the most common cause of dementia and the fifth leading cause of death in adults older than 65 years. The estimated total healthcare costs for the treatment of Alzheimer's disease in 2020 were estimated at $305 billion, with the cost expected to increase to more than $1 trillion as the population ages. Most of the direct costs of care for Alzheimer's disease are attributed to skilled nursing care, home healthcare, and hospice care. Indirect costs of care, including quality of life and informal caregiving, are likely underestimated, and are associated with significant negative societal and personal burdens.

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 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 Development
Toll-free: 1-844-689-3939
Email: info@anavex.com

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com

¹ Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
² W Wong Economic Burden of Alzheimer Disease and Managed Care Considerations Am J Manag Care. 2020;26:S177-S183.

 

FAQ

What is the purpose of the Phase 2b/3 study for ANAVEX®2-73?

The Phase 2b/3 study aims to evaluate the efficacy of ANAVEX®2-73 in treating Early Alzheimer's Disease.

When will the Phase 2b/3 results for ANAVEX®2-73 be presented?

The results will be presented on December 1, 2022, at the Clinical Trials on Alzheimer’s Disease (CTAD) Congress.

What are the implications of the ANAVEX®2-73 study results for the market?

Positive results could enhance Anavex's market position and attract investment, given the economic burden of Alzheimer's is projected to increase significantly.

What previous trials has ANAVEX®2-73 completed?

ANAVEX®2-73 has successfully completed Phase 2 trials for Alzheimer's disease, Parkinson's disease dementia, and multiple trials for Rett syndrome.