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As billionaires race to fund anti-aging projects, a much-discussed trial goes overlooked

By:  Megan Molteni

Beating back the diseases of aging has become something of a pet project for many of Silicon Valley’s tech titans. Earlier this year, Altos Labs, a partial cellular reprogramming company, drew billions of dollars of investment, including from Jeff Bezos and Yuri Milner. Google founders Sergey Brin and Larry Page have put billions into Calico. Peter Thiel was an early backer of Unity Biotechnology. Peter Diamandis is placing bets on young blood and stem cells.

But many researchers in the field of longevity science say there’s one project they wish these billionaires could find a little pocket change to fund: Nir Barzilai’s TAME Trial.

Barzilai, the head of the Institute for Aging Research at the Albert Einstein College of Medicine, and scientific director for AFAR — the American Federation for Aging Research — has for more than a decade been leading the charge to test the idea of using drugs to extend human healthspan.

In 2013, he and two other researchers got a grant from the National Institutes of Aging to develop a roadmap to conduct, for the first time in history, a clinical trial that targets aging. They planned to test metformin, a drug that had been approved in the ’90s for treating diabetes, and that was shown in epidemiological studies to prevent against conditions like heart attacks, cancer, and Alzheimer’s. It also turned out to be very safe, with few, generally mild side effects. And it’s dirt cheap: just six cents per dose.

STAT Reports: The race for longevity: How scientists — and industry — are seeking to extend healthy lives

The biggest obstacle they had was the Food and Drug Administration. The federal regulator adheres to a “one disease, one drug” model of approval. And because the agency does not recognize aging as a disease, there’s no path forward for a drug to treat it. And even if there was, it’s impractical to do a lifespan study — it would take decades and be astronomically expensive.

The solution then would be to use biomarkers as a proxy, as researchers have with other treatments. Statins, for example, are a class of drugs the FDA approved to prevent heart attacks. But initial clinical trials of the first statins didn’t test that explicitly because it would have taken too long. Instead, they tested for changes to cholesterol, a well-defined predictor of heart attacks. There are, however, no standard accepted biomarkers for aging, although scientists are actively searching for them.

Barzilai’s plan was to launch a new kind of gold-standard trial, designed to prove that the onset of multiple chronic diseases, or comorbidities, associated with aging can be delayed by a single drug: metformin. The ambitious effort aimed to track 3,000 elderly people over five years to see if the medicine could hold off cardiovascular disease, cancer, and cognitive decline, along with mortality.

“There’s nothing in that clinical trial that hasn’t already been shown before with metformin,” said Barzilai. “We are just trying to package it all up and call it aging so the FDA will approve this for aging.”

In 2015, he and a group of academics from more than a dozen top-tier universities met with the FDA to get its blessing for their Targeted Aging with Metformin, or TAME, trial. And to many people’s surprise, the agency agreed.

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All that was left was funding it. Because metformin is a generic drug from which no one could make any money, the trial’s sponsor wouldn’t be a pharmaceutical company, but AFAR. A trial of the scale researchers were proposing would cost between $30 million and $50 million. The National Institutes of Health offered up just a small portion, about $9 million, toward the difficult but important task of screening for the best biomarkers for assessing if the aging process is actually being slowed.

The rest of the money, Barzilai was convinced, could be raised from philanthropists. But despite interest from several people — at one point, Barzilai said, the Israeli American businessman Adam Neumann offered to pay for it all, before his WeWork empire evaporated — the required funds never materialized.

“Those big billionaires, they want moonshots, they want a scientific achievement that will make people say ‘wow,’” said Barzilai. “TAME is not a moonshot. It’s not even about scientific achievement really, it’s more about political achievement. Metformin is a tool to get aging as an indication.”

“The metformin story is a particularly tragic one,” said James Peyer, co-founder and CEO of Cambrian Biopharma, a 4-year-old company that has raised $160 million with its “hub and spoke” approach to develop more than a dozen different drug candidates aimed at diseases of aging.

Original Article: https://www.statnews.com/2022/08/09/anti-aging-projects-funding-much-discussed-trial-overlooked/

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