Following remarkable results in animal models, a telomere extension therapy developed by biotech company Rejuvenate Bio has received FDA clearance to begin Phase 1 clinical trials in humans. The therapy uses modified mRNA to temporarily activate telomerase, the enzyme that rebuilds protective telomere caps on chromosomes.
In preclinical studies, aged mice treated with the therapy showed a 30% extension of remaining lifespan, improved organ function, and restoration of youthful fur color and density. Critically, the treatment did not increase cancer risk — a long-standing concern with telomerase activation approaches.
"Our approach is fundamentally different from permanent telomerase activation," explained Dr. Noah Davidsohn, co-founder of Rejuvenate Bio. "We deliver a transient pulse of telomerase activity that extends telomeres without the sustained activation that could promote malignancy."
The Phase 1 trial will enroll 30 adults aged 65 to 80 with shortened telomeres. Participants will receive a single treatment and be monitored for safety and biological age markers over 12 months.
While experts urge caution about translating animal results to humans, the trial represents a significant milestone in the field of telomere biology. If successful, it could pave the way for periodic telomere maintenance treatments that slow biological aging.