Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA) - Seite 2

“There remains an urgent need for convenient once-daily oral treatment options for Alzheimer’s disease, and Anavex is moving forward to potentially addressing the preference for simple patient-centered administrations and shared decision-making,” said Christopher U Missling, PhD, President and Chief Executive Officer at Anavex.

In addition to significant improvement in dementia symptoms, blarcamesine demonstrated reduction of pathological aggregation of amyloid in early Alzheimer’s disease as well reduction of brain volume loss, a well-known marker of neurodegeneration.

Data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal.

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, ANAVEX2-73 (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 with Rett syndrome. ANAVEX2-73 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. ANAVEX2-73 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 ANAVEX2-73 for the treatment of Parkinson's disease. ANAVEX3-71, 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, ANAVEX3-71 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.