Phase 1 Longevity Trial Launches at GARM Clinic in Prospera, Roatán

Roatán is entering a new chapter in medical innovation. Klothea Bio has officially announced the launch of a Phase 1b clinical trial of AKL003, an investigational alpha Klotho mRNA therapeutic designed to explore the extension of human healthspan and lifespan. The randomized, double-blind, placebo-controlled study is now recruiting at a single site: GARM Clinic, located within the special jurisdiction of Prospera in Roatan, Honduras.

Beyond its scientific significance, this trial underscores how Prospera’s governance model enables advanced biomedical research to be conducted efficiently, ethically, and with international standards—positioning Roatán as an emerging destination for cutting-edge biotechnology.

Understanding Klotho: A Breakthrough in Longevity Science

The Klotho protein was discovered in 1997 by Professor Makoto Kuro-o and has since become one of the most compelling areas of research in aging biology. Elevated Klotho expression correlates with healthier aging and increased lifespan in humans. More than 4,000 studies have examined its role in protecting and repairing multiple organ systems, including:

• Cardiovascular tissue

• Kidneys

• Lungs

• Brain

• Bone structure

Despite its promise, safely and reliably increasing circulating alpha Klotho levels has proven clinically challenging.

Klothea Bio has developed and patented a proprietary serum Klotho platform designed to upregulate alpha Klotho levels using mRNA technology. Its lead candidate, AKL003, delivers a proprietary alpha Klotho mRNA sequence encapsulated in lipid nanoparticles. This enables the body’s own cellular machinery to produce the Klotho protein, potentially allowing controlled and repeatable dosing.

The company’s approach has already received global recognition. 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.

Phase 1b Trial Design: Scientific Rigor with Longevity-Focused Endpoints

The Phase 1b clinical study of AKL003 is structured to evaluate both safety and biological impact.

Study Highlights:

• Design: Randomized, double-blind, placebo-controlled, single-site

• Location: GARM Clinic, Prospera, Roatán

• Population: Healthy adults aged 25–75

• Sample Size: 21 participants

• Randomization: 2:1 (AKL003:placebo)

• Dosing: Two intravenous administrations approximately four weeks apart

• Primary Objective: Safety and tolerability

• Secondary Objective: Characterization of serum alpha Klotho levels over time

What differentiates this study from many early-stage clinical programs is its focus on longevity-relevant biomarkers. In addition to measuring circulating alpha Klotho levels, the protocol includes exploratory assessments such as:

• Inflammatory biomarkers

• Metabolic and cardiovascular measurements

• Mitochondrial function indicators

• Sleep and recovery metrics (including wearable-derived data)

• Quality-of-life questionnaires

By integrating classical Phase 1 safety evaluation with biomarkers directly associated with healthspan, Klothea Bio aims to generate foundational human data on the therapeutic upregulation of Klotho.

Professor Carmela Abraham, Chief Science Officer of Klothea Bio, emphasized that this trial is a critical step in understanding repeat dosing safety while rigorously measuring biological outcomes. Meanwhile, functional medicine physician Mark Hyman highlighted Klotho as one of the most promising frontiers in aging science.

Why Prospera Enables Advanced Clinical Research

The decision to conduct this Phase 1b study in Prospera is not incidental. Prospera operates under a special economic and regulatory framework designed to attract high-impact industries, including biotechnology, medical innovation, and life sciences.

Several structural advantages make Prospera uniquely suited for early-phase clinical research:

1. Regulatory Agility

Prospera’s governance model allows for streamlined regulatory pathways while maintaining international ethical and clinical standards. This reduces unnecessary bureaucratic delay without compromising participant safety.

2. International Participant Access

The study is actively recruiting eligible volunteers willing to travel to Roatán, facilitating a geographically diverse participant pool.

3. Infrastructure for Precision Medicine

GARM Clinic offers advanced diagnostic and biomarker monitoring capabilities aligned with longevity-focused research protocols.

4. Innovation-Oriented Jurisdiction

Prospera’s legal framework is designed to accommodate emerging biomedical technologies such as mRNA therapeutics, regenerative medicine, and longevity science—fields that often face regulatory friction in traditional systems.

In practical terms, this means that pioneering therapies like AKL003 can move from preclinical innovation into carefully designed human studies with greater efficiency.

Positioning Roatán as a Global Longevity Destination

Roatán has long been known for its natural beauty, diving, and eco-tourism. However, the launch of a cutting-edge mRNA longevity trial signals an evolution in the island’s global identity.

Hosting advanced biotechnology research accomplishes several strategic objectives for Roatán:

• Attracts international scientific talent and medical professionals

• Brings high-value medical tourism and research travel

• Encourages cross-border investment in life sciences

• Diversifies the island’s economic base beyond traditional tourism

As longevity science becomes a multi-billion-dollar global industry, jurisdictions capable of supporting translational clinical research will play an outsized role in shaping the future of healthcare.

Prospera’s model, combined with Roatán’s accessibility and international connectivity, creates an ecosystem where clinical innovation can thrive.

Participant Recruitment and Study Contact Information

Klothea Bio is currently recruiting healthy adult volunteers willing to travel to Roatán to participate in the study.

Recruitment Contacts:

• Douglas Tucker, M.D. (Principal Investigator)

• Fluvia Humphreys, M.D. (Sub-Investigator)

• Email: info@garmclinic.com

• US VoIP: (305) 848-0144

• Location: GARM Clinic, Prospera, Roatán, Honduras

The company expects to provide an update regarding the first participant dosed in the coming weeks, subject to enrollment progress and study procedures.

The Broader Implications for Biotechnology in Roatán

The launch of AKL003’s Phase 1b trial represents more than a single investigational therapy. It signals that Roatán, through Prospera, is becoming a viable jurisdiction for advanced biomedical research—particularly in high-growth domains such as:

• mRNA therapeutics

• Regenerative medicine

• Longevity and healthspan science

• Precision biomarker-driven trials

As global healthcare systems increasingly focus on extending healthspan rather than merely treating disease, research platforms that can responsibly test innovative interventions will be critical.

With Klothea Bio’s trial now underway at GARM Clinic, Roatán stands at the intersection of tropical paradise and translational biotechnology—demonstrating how forward-looking regulatory frameworks can catalyze real-world scientific advancement.