Anavex Life Sciences Corp (AVXL)

[sokol]

Restoring expression levels of genes associated with Alzheimer's disease seems highly significant in advancing AVXL 2-73's quest for approval.

Quote from today's AAIC Poster:
"Expression levels of dysregulated neurodegenerative genes were restored by the therapeutic effect of ANAVEX 2-73
• Both identified clusters are up-regulated for treated patients compared to placebo: Cluster 2 eigengene expression was significantly increased for patients treated with ANAVEX®2-73 high oral dose compared to placebo (p = 0.021)
• These genes are known to be down-regulated in the pathology of both Alzheimer’s disease1,2 and Parkinson’s disease3,4"

See also: Dysregulated gene-associated biomarkers for Alzheimer’s disease and aging. https://www.degruyter.com/document/doi/10.1515/tnsci-2021-0009/html?lang=en

"...the new crucial biomarkers for the diagnosis and pathogenesis of AD need to be explored further. Here, the common differentially expressed genes (DEGs) were identified through a comprehensive analysis of gene expression profiles from the Gene Expression Omnibus (GEO) database. Furthermore, Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway analyses revealed that these DEGs were mainly associated with biological processes, cellular components, and molecular functions, which are involved in multiple cellular functions. Next, we found that 9 of the 24 genes showed the same regulatory changes in the blood of patients with AD compared to those in the GEO database, and 2 of the 24 genes showed a significant correlation with Montreal Cognitive Assessment scores. Finally, we determined that mice with AD and elderly mice had the same regulatory changes in the identified DEGs in both the blood and hippocampus. Our study identified several potential core biomarkers of AD and aging, which could contribute to the early detection, differential diagnosis, treatment, and pathological analysis of AD."

And, recall the accelerated approval of Aduhelm wherein ... "Instead of direct evidence of a clinical benefit from the trials, the FDA's accelerated approval pathway relies on the use of a biomarker - a biological change prompted by the drug - that could likely predict a patient benefit." https://www.reuters.com/business/healthcare-pharmaceuticals/fda-documents-show-struggle-over-approval-new-alzheimers-drug-biogen-2021-06-22/

Here, AVXL 2-73 seemingly demonstrates a biological change that is associated with aging and onset of Alzheimer's disease as well as some direct evidence of clinical benefit in addition to the fact that that biological change “could likely predict a patient benefit….”