Published in Alzheimer’s & Dementia Journal, Results Highlight ANAVEX®2-73 (blarcamesine) Clinical Study, the First Reported Genome-Wide Search for Biomarkers Associated with Drug Response in Alzheimer’s Disease
Clinically Meaningful Biomarkers Identified in ANAVEX®2-73 (blarcamesine) Studies Demonstrate a Significant Impact on Clinical Outcomes At One Year (57 Weeks) and Beyond Three Years (148 Weeks)
Provides a Template for the Use of Big Data in Precision Medicine Studies of New Therapies for Neurological Disorders
NEW YORK – April 23, 2020
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 announced the publication in the peer-reviewed journal, Alzheimer’s & Dementia: Translational Research & Clinical Interventions, entitled, “A precision medicine framework using Artificial Intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer’s disease therapy: Analysis of the Blarcamesine (ANAVEX2-73) Phase 2a clinical study.“
“This study highlights the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease treatments,” said Dr. Harald Hampel, M.D., Ph.D., M.A., M.Sc., Founding President of the Alzheimer Precision Medicine Initiative (APMI) and lead author of the paper.
Alzheimer’s disease is a progressive, multi-factorial disease and the most common cause of primary neurodegenerative dementias. AD incidence in U.S. is approximately 5,700,000. It is estimated that 50 million people live with dementia worldwide. The current annual cost of dementia is estimated at $1 trillion, a figure set to double by 2030 and the expected burden on the healthcare systems is dramatic.
Today, there are no commercially available therapies to address the underlying biological cause of Alzheimer’s progressive cognitive decline.
“We believe that the analysis platform described in this work opens the possibility of using big data-driven unbiased genome-wide patient selection marker identification early on in the drug development process of CNS diseases, including Alzheimer’s disease, which is currently applied more routinely in the field of oncology,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
“Findings from this study were the basis for the testing of potential patient selection markers in our ongoing Phase 2b/3 Alzheimer’s disease (AD) study (NCT03790709), as well as the Parkinson’s disease dementia (PDD) (NCT03774459) and Rett syndrome (RTT) studies (NCT03758924, NCT03941444 and NCT04304482) with ANAVEX®2-73 (blarcamesine).”
The full paper can be accessed online at: (https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.12013).
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), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) 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 (blarcamesine) 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 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical 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 and LinkedIn.
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