Unlimited Bio registered a Phase 1/2a clinical trial on ClinicalTrials.gov (NCT07443826). The CALM-AF-AI trial will evaluate the safety and preliminary efficacy of combining AAV9-Follistatin with a VEGF plasmid to address age-related muscle decline, and the company claims it is the first registered clinical study worldwide to combine these two gene therapies.
The open-label, sequential dose-escalation study plans to enroll about 12 adults aged 45 to 75 at GARM Clinic in Roatán, Honduras, operating under applicable ethics oversight in the Próspera ZEDE special economic zone. The protocol uses a 3+3 design across three cohorts: low-dose AAV-Follistatin monotherapy at 5×10^10 vg/kg, high-dose monotherapy at 1×10^11 vg/kg, and a combination arm with 4.8 mg VEGF plasmid. Rapamycin will be co-administered for approximately two months to mitigate immune responses.
Primary safety endpoints are supplemented by 12-month exploratory functional and biomarker measures, including DXA lean mass, bone mineral density, leg press one-repetition maximum, grip strength, VO2max, six-minute walk distance, frailty scales and serum follistatin, myostatin and IGF-1 levels.
Immortal Dragons, a $40 million longevity fund that invested in Unlimited Bio in 2024, positioned the trial as a step to generate preliminary data to support future regulatory submissions.
