Klotho Neurosciences, Inc. (NASDAQ:KLTO) announced the launch of a new genomics diagnostics initiative centered on two epigenetics-based tests designed to support its clinical trials and expand applications in longevity research and biological aging assessment.
The company said the tools aim to improve understanding of the relationship between chronological age and biological age while enabling more precise patient selection for studies targeting neurodegenerative diseases.
One test under development is a quantitative DNA methylation assay that evaluates methylation levels of the anti-aging alpha-Klotho gene using cell-free DNA obtained through a blood sample. The company views DNA methylation of the Klotho gene as a validated biomarker of biological aging.
The second diagnostic platform, named the “Klotho Clock,” will analyze DNA and mRNA sequences from the Klotho gene alongside eight additional genes associated in scientific literature with longevity and healthy lifespan. The combined genetic and transcriptomic analysis is intended to confirm not only gene presence but also active protein expression.
Dr. Joseph Sinkule, founder and chief executive officer of Klotho Neurosciences, said the initiative is designed to improve clinical trial design and patient stratification.
“This is a unique opportunity to qualify patients with neurodegenerative diseases for our clinical trials to assure that our randomized studies are balanced and stratified based on biologic age and the extent of DNA methylation of the human Klotho gene and promoter. Similar to many other human genes, the hypermethylation of the Klotho gene and its promoter are key events that occur over time that ultimately silence the gene and lower the Klotho protein levels in all tissues. Balancing the biological age of people going into our randomized studies will minimize the possibility of overloading the placebo group with healthier, ‘less biologically aged’ people in the placebo arm versus the treatment arm of our studies.”
To lead development of the diagnostic platform, the company has appointed Dr. Bret Barnes, who previously spent 18 years at Illumina working on DNA methylation assays and next-generation sequencing informatics.
Dr. Barnes highlighted the technical differentiation of the platform, stating, “Unlike other genomic tests on market, Klotho Neurosciences’ assay employs novel, cutting-edge probe designs to address underlying human genetic variation, while simultaneously providing increased accuracy at a lower assay cost. The increased information from these novel designs can seamlessly integrate into our AI-based clocks. Besides DNA methylation detection, the software supporting our assay can provide information on Copy Number Variants (‘CNVs’) and Single Nucleotide Variants (‘SNVs’), thus creating new, more robust ‘multiomics’ capabilities.”
Klotho expects to complete a prototype version of the assay in 2026, after which it plans to commercialize a more efficient and cost-effective diagnostic offering. The company said the platform could generate near-term revenue while supporting the creation of a growing biological database to refine future aging “clock” models and discoveries.
About Klotho Neurosciences, Inc.
Klotho Neurosciences is a gene and cell therapy company focused on developing disease-modifying treatments based on the anti-aging Klotho protein (s-KL), tissue-specific promoters, and targeted delivery technologies. Its programs target neurodegenerative conditions including ALS, Alzheimer’s disease, and Parkinson’s disease, as well as age-related neurological, ocular, skeletal, and muscular disorders. The company’s “Klotho Clock” initiative is intended to deepen understanding of biological aging and longevity while supporting therapeutic development.