AgelessRx and funding an IRB-approved rapamycin trial

Rapamycin could be the PEARL in the Longevity oyster as new human trial seeks funding.

AgelessRx is a platform that sells drugs and supplements including metformin and NAD+. The company is in the business of combating age and age-related diseases and they are seeking crowdfunding for a human trial of rapamycin, a drug that has performed positively for aging in animal trials.

We spoke to Anar Isman, Co-founder & CEO of AgelessRx to find out more about the trial and what it could mean for Longevity.

Longevity.Technology: Rapamycin is making headlines, and the start of a trial that investigates its Longevity ability in humans is an exciting development, albeit on a small and crowd-funded scale. AgelessRx claims that PEARL is the first nationwide telemedicine trial and one of the first large-scale intervention trials on Longevity. Along with TAME, there is an appetite for clinically evaluating drugs with Longevity properties and seeing how they can be shaped into a Longevity market.

Isman has his sights set firmly on rapamycin, which is already used as an immunosuppressant taken by transplant patients, but which has demonstrated Longevity potential in lab tests.

“We have doctors who are knowledgeable about rapamycin,” he explains “but due to current regulatory environment they are having a hard time prescribing rapamycin for Longevity over telemedicine. We are hoping our rapamycin trial will show it is safe and effective, and then we can consider adding it to our platform.”

Anar Isman is confident about the safety aspect of rapamycin and the proposed trial has gained Institutional Review Board (IRB) approval . “There’s a lot of data on rapamycin showing that it’s safe,” he explains, “so we have a pretty high certainty that this trial will show it’s safe too.

The human trial is a stepping stone to the way to bringing rapamycin to the Longevity market. PEARL (Participatory Evaluation of Aging with Rapamycin for Longevity) is being run in affiliation with the University of California, with Dr James Watson at UCLA as the principal investigator, and will evaluate the safety and effectiveness of rapamycin in healthy adults for Longevity in double-blind, randomised, placebo-controlled trial.

Interested patients will be screened for eligibility using telemedicine. Eligible patients include those aged 50-85 of any sex, any ethnicity, in relatively good health, with only well-managed, clinically stable chronic diseases.

“We’ll be doing close to $3,000 of testing per person,” he explains. “This includes the Horvath clock and methylation peak testing, to see if rapamycin slows down your biological age.”

“We are looking to enrol 200 people in five groups of forty – four different dosing groups and a placebo,” Isman explains. “We’ll try to make sure to demonstrate that it’s safe, so we will measure a lot of different blood biomarkers to make sure that rapamycin doesn’t impact your immune system, your cholesterol, or any other commonly-assessed safety measures.”

But effectiveness is also a key trial demonstrable, says Isman.
“We’ll be doing close to $3,000 of testing per person,” he explains. “This includes the Horvath clock and methylation peak testing, to see if rapamycin slows down your biological age. We’ll do microbiome testing, glycan age testing, bone density scan, visceral fat measurements, among others, and we’ll see if over the six months of the trial if rapamycin shows any Longevity benefits through those tests.”

There is animal data from trials, and Isman also references Dr Alan Green, a New York physician who has been prescribing rapamycin for Longevity out of his personal clinic, and who has seen “really remarkable data”, although not structured in a way that would be considered to be a scientific trial.

Like metformin, which is the subject of the highly-anticipated TAME (Targeting Aging with Metformin) trial, rapamycin could a drug that’s set to expand its indication.

“Metformin is generic, so no-one in big pharma really has any incentive to test it for other indications,” Isman says. “Rapamycin is the same – it’s all open source, so we’re not suddenly going to patent it and apply a high price. The opposite applies, in this case; any doctor in the US, or in the world, will benefit from that information.”

The fund-raising for the trial is nearly complete, as Isman explains: “It takes pharma and biotech companies tens of millions of dollars to test drugs and bring them to the market.
“Our rapamycin trial is only costing $600,000 – that’s $3,000 per person for 200 people. We have $150,000 committed from various policy donors, and there will also be a crowdfunding campaign to raise $100,000. There is also a waiting list of a thousand people for this trial, for 200 places that will cost the participants $1,000 and for which they’ll get $3,000 worth of testing.”

And the remaining $150,000?
“I’m working on it!” says Isman. “We’re hoping for some additional grants … if this trial ends up being funded completely, and works, the next step will be a senolytics trial – dasatinib and quercetin, for example. For a few hundred thousand dollars we could do a clinical trial and show if it is safe and effective. If it is, we can make it accessible on our platform.”

In the future, Isman thinks that combinations of drugs might prove to be the best recipe for Longevity, teaming rapamycin with metformin, or NAD+, with personalised regimes achieving the best results.

“Metformin is very well known and taken by 60 million people; we know it’s a helpful drug, but we also know it’s not super-helpful – it’s not a magic drug, or there would be lots of 150-year-old diabetics walking around!”

TAME is a series of nationwide, six-year clinical trials at 14 research institutions across the US, that will involve 3000 participants. PEARL is obviously on a smaller scale, but Anar Isman is hopeful it will generate useful results.

“First we need to show it is safe, then that it’s effective; rapamycin hasn’t really been studied in healthy people, so we have a range of tests to do and changes to look for. We’ll be studying the data after six months and twelve months.

“The crowd-funding starts in December, and we hope to start enrolling participants in January. We aim to release data as soon as possible, once our scientific community has signed off, so hopefully mid-late summer 2021.”

We have a follow-up interview with Anar Isman coming soon in which he discusses AgelessRx’s platform and his plans for personalised medicine.