Unlimited Bio has initiated the CALM-AF-AI trial, marking a significant advancement in the longevity field as it becomes the first registered clinical study globally to evaluate the combination of AAV9-Follistatin and a VEGF plasmid for combating age-related muscle decline. This Phase 1/2a open-label trial will enroll approximately 12 adults aged 45 to 75 at the GARM Clinic in Roatán, Honduras, under ethical oversight in the Próspera ZEDE special economic zone.

The trial’s innovative design employs a 3+3 dose-escalation approach, assessing both low and high doses of AAV-Follistatin monotherapy alongside a combination therapy. Co-administration of rapamycin aims to mitigate immune responses, while primary safety endpoints will be complemented by a range of functional and biomarker assessments over 12 months. The involvement of Immortal Dragons, a $40 million longevity fund, underscores the trial’s potential to provide critical data for future regulatory submissions.

This trial represents a promising step towards understanding the therapeutic potential of gene therapies in addressing muscle decline, a key factor in healthspan extension.

Source: longevity.technology