Klothea Bio Launches Phase 1b Trial of Alpha Klotho mRNA Therapy for Lifespan Extension

Klothea Bio, Inc., a clinical-stage biotechnology company, has launched a randomized, double-blind, placebo-controlled Phase 1b clinical study evaluating AKL003, its investigational alpha Klotho mRNA therapeutic. Recruitment has commenced at the single study site at GARM Clinic, located in the special jurisdiction of Prospera, Roatan, Honduras.

Klotho is a longevity-associated protein discovered in 1997. Its higher expression is correlated with healthy aging and hence a longer lifespan, including in humans. More than 4,000 studies have shown its influence in the protection and repair of multiple organs including heart, kidneys, lungs, brain, and bones. Upregulating Klotho has proven clinically difficult; Klothea Bio has developed and patented an approach that has demonstrated the ability to successfully and repeatedly upregulate serum klotho levels.

The Phase 1b study of AKL003 is designed to assess the safety and tolerability of multiple administrations in healthy adult volunteers and to measure serum alpha Klotho protein expression following dosing as well as several biomarkers associated with longevity. Participants will receive two intravenous administrations approximately four weeks apart, with subjects randomized from 2:1 to AKL003 or placebo. The study will enroll twenty-one participants ages 25 to 75 years.

In collaboration with Healthy Longevity Clinic, Klothea Bio's klotho mRNA candidate was named a semifinalist in the $101 million XPRIZE for Healthspan due to its ability to significantly upregulate serum alpha-klotho in a dose dependent manner.

Beyond measuring serum alpha Klotho protein levels, the protocol includes assessments spanning biomarkers and functional domains commonly associated with healthy aging, including inflammatory markers, metabolic and cardiovascular measurements, sleep and recovery metrics, mitochondrial function, and quality-of-life questionnaires. The study also measures epigenetic clocks. By pairing early clinical safety evaluation with longevity-relevant readouts, Klothea Bio aims to generate foundational human data on the novelty of increasing Klotho, a protein linked to healthy aging and extended lifespan.

This represents one of the first human longevity trials designed around lifespan as the primary endpoint rather than disease. The investigational product is alpha Klotho mRNA formulated in lipid nanoparticles administered intravenously; placebo is saline.