Immortal Dragons-backed Unlimited Bio registers world-first dual gene therapy trial to target age-related muscle loss and vascular decay.
One of the biggest problems in longevity is also one of the most visible: as we age, muscle quietly slips away. That loss does more than make it harder to lift weights or climb stairs. It chips away at mobility, resilience and independence – the very things that make a longer life worth having. That is the backdrop for a newly registered clinical trial from Unlimited Bio, a portfolio company of Singapore-based longevity fund Immortal Dragons, which is now testing a bold new approach to age-related muscle decline.
Unlimited Bio has registered a Phase 1/2a study on ClinicalTrials.gov (NCT07443826), called CALM-AF-AI, to evaluate the safety and early signals of efficacy of a dual gene therapy approach aimed at preserving and rebuilding aging muscle [1].
According to the company, the trial is believed to be the first registered clinical study worldwide to combine AAV9-Follistatin with VEGF plasmid gene therapy in a single protocol. In longevity, novelty is about whether a new idea changes how we think about aging itself.
Two therapies, one aging problem
At its core, the trial is trying to solve a simple problem with a more systems-level answer.
One part of the therapy uses follistatin, delivered through an AAV vector. In plain terms, it is designed to block myostatin, a natural protein that acts like the body’s “brake pedal” on muscle growth. Ease off that brake, and muscles may have more room to grow or resist decline.
The second part uses a VEGF plasmid, which is intended to promote the growth of new, small blood vessels. Think of it as improving the road network that delivers oxygen and nutrients to muscle tissue.
Separately, those ideas are already compelling. Together, they suggest something more interesting: not just building more muscle, but also improving the support system that helps that muscle function and endure.
For longevity investors and researchers, that combination is the real story. Aging rarely breaks one thing at a time; it is a network problem. Muscle loss is not just about weaker fibers, but also about poorer circulation, slower recovery and declining systemic resilience. A therapy that addresses more than one layer of that decline hints at where the field may be heading.
The CALM-AF-AI trial is an open-label, sequential dose-escalation study expected to enroll around 12 eligible adults aged 45 to 75 at GARM Clinic in Roatán, Honduras, under applicable ethics oversight.
This is an early-stage study, so the main goal is safety Iin other words, can this be given without causing serious problems? But the researchers are also looking for early signs that it might help.
They will track a wide range of outcomes over 12 months, including lean muscle mass, bone density, leg press strength, grip strength, aerobic fitness, walking distance and frailty measures. That is important because it shifts the focus away from abstract lab numbers and toward whether the body performs better in daily life.
The study is designed to generate preliminary safety data and exploratory outcome data for combination gene therapy in eligible participants.
Immortal Dragons first invested in Unlimited Bio in 2024, and this trial now gives that conviction a clinical milestone.
“We backed Unlimited Bio because they had the courage to treat aging like what it is: a systems-level engineering problem,” said Boyang Wang, Founder of Immortal Dragons. “We believe this research may contribute preliminary data towards our thesis – combinatorial gene therapy for aging and help it move from conviction into clinical reality.”
In longevity, capital is increasingly flowing toward platforms that treat aging not as a single disease, but as a cluster of interconnected failures. The logic is familiar to anyone watching the sector: if aging drives frailty, loss of muscle, slower recovery and a higher risk of downstream disease, then targeting the biology of aging upstream may create broader healthspan gains than chasing one diagnosis at a time.
A regulatory workaround and a signal
The trial is being conducted in Próspera ZEDE, a Special Economic Zone with a more flexible framework for biomedical innovation. That is notable, but not surprising.
Age-related muscle decline still occupies a difficult regulatory space because aging itself is not formally recognized by major regulators as a disease. That creates a recurring bottleneck in longevity: science may move faster than policy. Running an early study in a jurisdiction willing to evaluate such interventions under local regulatory and ethics oversight, including IRB review, offers a way to generate initial data that could later support more traditional development pathways. In that sense, the trial is also testing a route forward for the longevity field.
This matters for longevity
If the trial succeeds, even modestly, it could strengthen a growing argument in longevity medicine: that the future may belong to combination therapies built around function rather than just biomarkers.
Living longer is one thing. Staying strong enough to carry groceries, recover from illness, travel, work and remain independent is another. Muscle is not cosmetic in the context of aging; it is infrastructure.
This trial stands out. It is early, small, and far from definitive, but it is also pointed at one of longevity’s most practical questions: how do we preserve the body’s capacity to remain useful to the person living in it?
Unlimited Bio’s newly registered study brings the conversation back to earth and back to the real promise of longevity.
