Libella Gene Therapeutics has received approval from an institutional review board (IRB) to conduct a clinical trial in Colombia of a gene therapy intended to treat and reverse ageing.
The study will be a pay-to-play model where volunteers have to pay $1m for enrolment in their country. Participants will then travel to Colombia to sign their consent.
Libella’s gene therapy will be administered to participants under a controlled hospital setting.
Many scientific peer-reviewed studies found the shortening of telomeres to be the primary reason for human ageing. Telomeres, which are considered as the body’s biological clock, shorten each time a cell divides.
Some studies also indicated that lengthening of telomeres can potentially reverse actual age.
Based on this, Libella developed a gene therapy to express active telomerase (hTERT) in humans. The hTERT will be delivered through AAV transduction.
The gene therapy is intended to extend the telomeres in order to prevent, delay or even reverse ageing.
Libella chief scientific officer Bill Andrews noted that the company’s gene therapy delivery system was observed to be safe and had minimal adverse reactions in approximately 200 clinical trials.
In the Phase I trial, the gene therapy will be evaluated for its safety and tolerability in approximately five participants. It is expected to be completed in 2021.
The primary endpoint is the incidence of adverse events, while secondary outcomes are hTERT expression and telomerase activity.
Libella Therapeutics president Dr Jeff Mathis said: “Traditional clinical trials in the US can take years and millions, or even billions, of dollars. The research and techniques that have been proven to work are ready now.
“We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster and at a lower cost in Colombia.”
The company added that the telomerase gene therapy demonstrated the ability to delay ageing and increase longevity when tested in mice.
Apart from ageing, the company is developing gene therapies for Alzheimer’s disease and critical limb ischemia.