Klothea Bio Launches Phase 1b Trial of AKL003 Alpha Klotho mRNA Therapy in Healthy Adults

February 19, 2026 -Klothea Bio has announced the initiation of a randomized, double-blind, placebo-controlled Phase 1b clinical study evaluating AKL003, its investigational alpha Klotho mRNA therapeutic. Recruitment has begun at a single study site, GARM Clinic, located in the special jurisdiction of Prospera, Roatan, Honduras.

AKL003 is designed to increase circulating levels of alpha Klotho, a longevity-associated protein first discovered in 1997 by Makoto Kuro-o. Higher expression of Klotho has been correlated with healthy aging and extended lifespan in multiple species, including humans. More than 4,000 studies have explored its role in organ protection and repair, with evidence suggesting involvement in cardiovascular, renal, pulmonary, neurological, skeletal, and metabolic health.

Despite strong biological rationale, therapeutic upregulation of Klotho has historically proven challenging. Klothea Bio has developed and patented a serum Klotho platform based on mRNA technology formulated in lipid nanoparticles (LNPs), designed to drive controlled and repeatable increases in circulating alpha Klotho levels. The company believes this approach may ultimately be tailored for diverse applications, including interventions aimed at extending human health span.

The Phase 1b study will enroll 21 healthy adults aged 25 to 75 years. Participants will be randomized 2:1 to receive AKL003 or placebo (saline), with two intravenous administrations approximately four weeks apart. The primary objective is to evaluate safety and tolerability following repeat dosing. A key secondary objective is to characterize serum alpha Klotho protein levels over time.

In addition to safety endpoints, the trial incorporates an extensive panel of exploratory biomarkers associated with longevity and health span. These include inflammatory markers, metabolic and cardiovascular parameters, sleep and recovery metrics (including wearable-derived data), mitochondrial function assessments, and quality-of-life questionnaires. By integrating early clinical safety evaluation with aging-relevant biological readouts, Klothea Bio aims to generate foundational human data on the impact of increasing circulating Klotho.

The company’s Klotho mRNA candidate was previously named a semifinalist in the $101 million XPRIZE for Healthspan in collaboration with Healthy Longevity Clinic, based on its dose-dependent ability to upregulate serum alpha Klotho levels. With this randomized controlled Phase 1b trial, Klothea Bio seeks to further validate those early signals under rigorous clinical conditions.

Enrollment is now open for eligible volunteers willing to travel to Roatan, Honduras.