A Discussion of What is Need to Speed the Pace at which Drugs to Treat Aging Arrive in the Clinic

Today I'll point out an opinion piece on how to get drugs to treat aging into the clinic as fast as possible. This is a moderately conservative viewpoint, focused on what will most rapidly produce the necessary regulatory changes to allow approval of new therapies specifically for the treatment of aging. At present regulators will only approve therapies to treat specific diseases of aging. The present focus of the industry is to produce treatments for specific age-related disease based on underlying technologies that target one or more mechanisms of aging, conforming to the present regulatory regime. The author makes the fair point that if one is focused on treating a given disease, then that is likely going to be at the expense of treating aging generally; that a therapy will be optimized to the specific disease rather than to the broader landscape of aging, and worse for it.

That said, I think that the basically sensible outline of lobbying, regulatory change, and industry and patient advocate activities laid out in the opinion piece are only likely to happen at a rapid pace in the US (or EU) once some other jurisdiction is very publicly offering therapies that successfully treat aging in some clear, measurable way. That is typically how the FDA operates, in any case, as illustrated by the history of first generation stem cell therapies, which were widely available via medical tourism for years before the FDA finally relented somewhat under pressure. Thus the best thing that could be done to accelerate the availability of therapies to treat aging may well be to make them available via medical tourism, and accumulate compelling human data while doing so.

Longevity biotech: a different strategy

It may be possible to treat an age-related disease by targeting a mechanism of aging and I think some companies will eventually achieve that. However, the treatment would be optimised for treating the disease; and not necessarily for slowing down aging. Running clinical trials to get any drug approved for an indication is by itself extremely difficult. And the best way to increase the chances of success is to optimise every detail. It may be dosage, formulation, biomarkers, protocol, duration or anything in between. From an investment perspective, given the scientific and historical risks, a drug that targets a specific pathway or mechanism of aging to treat a disease has no superior value than any other drug. Unless that drug can slow down aging. And it is probable that at least some of the drugs from all the longevity biotech startups that are currently active could do that.

You only get good at what you do. Not at what you say you do, not at what you think you're doing and definitely not at what you hope you will one day do. If a company is developing drugs that target a mechanism involved in the aging process to treat a disease, that's what they are doing. So that's what they are getting good at. And that's what they will eventually achieve. However, if a company aims at slowing down the aging process and extend healthy lifespan, that's what the they should do. And that's what they will eventually achieve. So maybe it's worth considering a different product strategy: assume the regulatory risk, target aging itself and go for preventative instead of curative studies.

The challenges are indeed extremely difficult but fundamentally simple: (1) Identify drugs that can potentially slow down the aging process at a molecular and cellular level that are safe, affordable and easy to distribute. (2) Understand how to run rigorous longevity clinical trials in a reasonable time at low cost. (3) Collaborate with regulators to find new pathways to market for geroprotectors. It is essential to overcome the agreed pessimism and skepticism towards regulatory agencies and their willingness to challenge the status quo. Current health care systems cannot survive the growth of the aging population so I'm positive we can work collaboratively with regulatory agencies like the FDA and EMA to cautiously explore responsible ways to evolve our healthcare system towards more preventative medicine

The longevity space will differentiate itself from traditional biotech and thrive (trillions of dollars pouring in every year) if and only if a company manages to commercialise a product that has been clinically proven to slow down the aging process and extend healthy lifespan. For that, a different approach should be considered. It may be fundamentally different than the traditional biotech playbook: spin-out a biotech company around a novel discovery, gather enough pre-clinical data to raise capital for running real world clinical trials or sell the intellectual property to another pharmaceutical or biotech company. Instead of being about how can this reach the market; it's about how can a market be created as soon as possoble. And the way to do that is by targeting aging itself preventatively instead of curatively and assuming the regulatory risk.


"the best thing that could be done to accelerate the availability of therapies to treat aging may well be to make them available via medical tourism, and accumulate compelling human data while doing so." I agree, and that's why I am spending January and February at Vitalia, to contribute whatever I can to their progress in that exact direction. I consider Prospera to be the most promising place in the world for this effort right now.

Posted by: Aubrey de Grey at December 31st, 2023 3:16 PM
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