Klothea Bio Launches Phase 1b Trial of AKL003 mRNA Therapy Targeting Longevity Protein Klotho
核心洞察
Klothea Bio (搜索) has initiated a randomized, double-blind, placebo-controlled Phase 1b clinical trial evaluating AKL003 (搜索), an investigational alpha Klotho (搜索) mRNA therapeutic designed to extend human lifespan.
The study will enroll 21 healthy adults aged 25-75 years at GARM Clinic (搜索) in Prospera, Roatan, Honduras, with participants receiving two intravenous administrations four weeks apart in a 2:1 randomization ratio.
AKL003 (搜索) was named a semifinalist in the $101 million XPRIZE for Healthspan due to its ability to significantly upregulate serum alpha-klotho (搜索) levels in a dose-dependent manner.
Klothea Bio (搜索) has commenced recruitment for a Phase 1b clinical trial of AKL003 (搜索), an investigational alpha Klotho (搜索) mRNA therapeutic designed to upregulate levels of the longevity-associated protein Klotho (搜索). The randomized, double-blind, placebo-controlled study represents a pioneering effort to translate Klotho biology into human therapeutics aimed at extending lifespan.
Novel mRNA Approach to Longevity Enhancement
AKL003 (搜索) utilizes a proprietary alpha Klotho (搜索) mRNA sequence formulated in lipid nanoparticles, administered intravenously to enable the body's own cells to produce alpha Klotho protein. Klothea Bio (搜索) refers to this approach as "Klotho (搜索) hormone supplementation" with the goal of increasing circulating levels of the longevity protein.
The investigational therapy gained recognition as a semifinalist in the $101 million XPRIZE for Healthspan due to its demonstrated ability to significantly upregulate serum alpha-klotho (搜索) levels in a dose-dependent manner. This achievement was accomplished in collaboration with Healthy Longevity Clinic (搜索).
Clinical Trial Design and Endpoints
The Phase 1b study will enroll 21 healthy adult volunteers aged 25 to 75 years at GARM Clinic (搜索), located in the special jurisdiction of Prospera, Roatan, Honduras. Participants will receive two intravenous administrations approximately four weeks apart, with subjects randomized 2:1 to AKL003 (搜索) or placebo (saline).
The primary objective focuses on evaluating the overall safety and tolerability of two administrations, while the key secondary objective aims to characterize serum alpha Klotho (搜索) protein levels over time following dosing.
Comprehensive Longevity Biomarker Assessment
Beyond standard safety evaluations, the trial incorporates an extensive panel of exploratory biomarkers associated with healthspan and longevity. These assessments include inflammatory markers, metabolic and cardiovascular measurements, sleep and recovery metrics derived from wearable devices, mitochondrial function analysis, and quality-of-life questionnaires.
"This Phase 1 study is an important step to evaluate the safety and tolerability of repeat dosing and to better understand how AKL003 (搜索) influences circulating alpha Klotho (搜索) protein levels in humans," stated Professor Carmela Abraham, Chief Science Officer at Klothea Bio (搜索).
Scientific Foundation and Expert Support
Klotho (搜索), discovered in 1997 by Professor Makoto Kuro-o, is a longevity-associated protein whose higher expression correlates with healthy aging (搜索) and extended lifespan in humans. More than 4,000 studies have demonstrated its protective and reparative influence across multiple organs including the heart, kidneys, lungs, brain, and bones.
Professor Kuro-o, who serves on Klothea Bio (搜索)'s Scientific Advisory Board, commented: "The discovery of Klotho (搜索) opened a new field of research into mechanisms that may influence healthy aging (搜索). I am encouraged to see continued efforts to translate Klotho biology into carefully designed clinical studies, and I look forward to learning from the data generated in this Phase 1 trial."
Dr. Mark Hyman, Functional Medicine Physician and Scientific Advisory Board Member, emphasized the significance of the work: "The Klotho (搜索) protein represents one of the most compelling frontiers in the science of aging (搜索), and Klothea Bio (搜索) is leading the way by translating it into therapies that can extend and improve human health span."
Recruitment and Study Timeline
Klothea Bio (搜索) is actively recruiting eligible volunteers willing to travel to Roatan for the study. Interested participants can contact the study team led by Principal Investigator Douglas Tucker, M.D., and Sub Investigator Fluvia Humphreys, M.D., at info@garmclinic.com or (305) 848-0144.
The company expects to provide an update on the first participant dosed in the coming weeks, subject to enrollment progress and study procedures. Klothea Bio (搜索) has developed and patented an approach that has demonstrated the ability to successfully and repeatedly upregulate serum klotho (搜索) levels, which the company believes may be tailored to various therapeutic applications including lifespan extension.