Klothea Bio Announces the Launch of a Phase 1b Clinical Trial of AKL003, an Alpha Klotho mRNA Therapeutic, for the Extension of Human Lifespan

MIAMI, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Klothea Bio, Inc. (“Klothea Bio”), a clinical-stage biotechnology company developing therapeutics based on their proprietary serum klotho platform, today announced the launch of 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 by Professor Makoto Kuro-o. 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. This approach may be tailored to the needs of various users, including toward the aim of extending human lifespan.

“The discovery of Klotho opened a new field of research into mechanisms that may influence healthy aging. 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.”

— Professor Makoto Kuro-o, Discoverer of Klotho and Scientific Advisory Board Member, Klothea Bio

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 a-klotho in a dose dependent manner. Klothea Bio has high conviction about exploring the very promising signals that led to the XPRIZE nomination in a randomized controlled trial.

“Klotho is a hormone-like protein implicated in multiple beneficial biological processes associated with healthy aging. This Phase 1 study is an important step to evaluate the safety and tolerability of repeat dosing and to better understand how AKL003 influences circulating alpha Klotho protein levels in humans. We are excited to begin enrollment and to advance our program with scientific rigor and a strong focus on participant safety.”

— Professor Carmela Abraham, Chief Science Officer, Klothea Bio

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.

In addition to safety and tolerability, this Phase 1b study will evaluate a set of exploratory biomarkers associated with health span and longevity. These endpoints differentiate this trial from most early-stage clinical programs by focusing squarely on endpoints that correlate with extended lifespan. 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. 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.

“I am particularly excited about the pioneering work being done on Klotho at Klothea Bio. The Klotho protein represents one of the most compelling frontiers in the science of aging, and Klothea Bio is leading the way by translating it into therapies that can extend and improve human health span. I look forward to supporting the team in advancing this breakthrough science toward meaningful clinical impact.”

— Dr. Mark Hyman, Functional Medicine Physician and Scientific Advisory Board Member, Klothea Bio

Study Highlights:

Design: randomized, double-blind, placebo-controlled, single-site study at GARM Clinic located in Prospera, Roatan, Honduras.
Population: healthy adults ages 25 to 75 years.
Investigational product: AKL003 (alpha Klotho mRNA formulated in lipid nanoparticles) administered intravenously; placebo is saline.
Dosing: two administrations approximately four weeks apart.
Randomization: 2:1 (AKL003:placebo).
Primary objective: evaluate overall safety and tolerability of two administrations.
Key secondary objective: characterize serum alpha Klotho protein levels over time following dosing.
Exploratory assessments: biomarkers and clinical measures such as inflammatory markers, metabolic and cardiovascular measures, sleep quality (including wearable-derived data), and quality-of-life questionnaires.

Participant Recruitment

Klothea Bio is now recruiting eligible volunteers who are willing to travel to Roatan for this study. Individuals interested in learning more about participation may contact the study team:

Recruitment Contact:

Douglas Tucker, M.D. (Principal Investigator)
Fluvia Humphreys, M.D. (Sub Investigator)
Email: info@garmclinic.com
US VoIP: (305) 848-0144
Study Location: GARM Clinic, Prospera, Roatan, Honduras

Klothea Bio expects to provide an update on first participant dosed in the coming weeks, subject to enrollment progress and study procedures.

About AKL003 and Klotho Supplementation

Klotho is a protein implicated in multiple biological processes associated with healthy aging. Klothea Bio refers to its approach as “Klotho hormone supplementation” because its goal is to increase circulating levels of alpha Klotho protein. AKL003 is designed to support endogenous supplementation by delivering a proprietary alpha Klotho mRNA sequence in a lipid nanoparticle formulation, enabling the body’s own cells to produce alpha Klotho protein using their cellular machinery. Klothea Bio believes the mRNA approach may enable controllable, repeatable dosing while producing appropriately processed protein.

About Klothea Bio

Klothea Bio is a biotechnology company developing investigational therapeutics intended to increase levels of the Klotho protein and explore its potential to support healthy aging. Klothea Bio’s pipeline includes AKL003, an investigational alpha Klotho mRNA therapeutic.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the initiation, design, timing, enrollment, conduct, and anticipated milestones of the AKL003 clinical study, as well as the potential of AKL003 and Klotho hormone supplementation. Forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the ability to obtain and maintain required regulatory and ethics approvals, participant recruitment and retention, operational execution, safety findings, and other risks inherent in clinical development. Klothea Bio undertakes no obligation to update any forward-looking statements, except as required by law.

Media & Investor Contact

Venessa Santos
Legacy Media and Public Relations
(361) 438-0114
venessa@legacymediapr.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.