FDA Approves Efficacy Data for Loyal’s Dog Longevity Drug

Wow.

Folks, for the first time ever, we will see an FDA-approved drug to extend lifespan.

Loyal just announced that FDA has accepted their efficacy section for life extension in large dogs. This is a stunning development, for both veterinary and longevity fields. This means that they have cleared the biggest hurdle for getting a drug to market that extends lifespan. This also means FDA, at least the veterinary division, is open to the indication of lifespan extension. More importantly, it means that it’s probably possible to extend lifespan even in non-laboratory animals.

There are couple of caveats. Loyal is applying for a conditional approval, which means the data will eventually need to be confirmed in another study — but of course, this is to be expected for a longevity drug. And they still need safety and manufacturing sections of their application approved. And it’s for large dogs only, who may have an accelerated rather than normal aging. But it’s a major step forward. And of course, there are some ethical implications, which a NY Times article discusses. And it brings some other issues to the fore — for example, one of the comments on the article is:

“How many people will be taking these drugs in the hope that it might work for them too? One for you, one for me…”

Lol. Don’t do that, folks.

But the net take-away is that it means we’re another step closer to getting an effective life extension therapeutic for humans.

The beauty of this breakthrough is that the target is exactly what you would have expected. The very first gene shown to control aging in any animal (at a time when it was believed no such genes existed) was DAF-2 in C. elegans worm by Cynthia Kenyon. DAF-2 is the worm’s equivalent of IGF receptor. And get this: the one gene that separates big dogs that live for 7–8 years from little dogs for 15–20 years is IGF receptor. Small dogs have a mutation in the IGF receptor.

And in many other species, including humans, IGF receptor mutations confer remarkable resistance to cancer, diabetes, and other drugs — along with dwarfism. It along prolongs life in those dwarf species substantially, although its effect on human lifespan is difficult to assess because humans with the mutation (Laron dwarfism) die so frequently from accidents.

And the drug Loyal is developing works by reducing IGF levels in dogs. No surprise. Based on biology, you would predict the drug to work.

The great thing about this is that the studies seem to have been done on non-laboratory dogs. This means that it is likely to be reproducible in humans.

You see, the reason that most animal studies don’t translate well into humans is not because we’re crossing species boundaries. It’s because we’re taking data from a laboratory animal that has a model of a disease and trying to apply it to humans with real disease. A mouse that had a lump of tumor cells inserted under the skin doesn’t have real cancer. It just has a lump of cancer cells under its skin. To take an extreme example, if you paint a red rash on an animal, it doesn’t mean it has a skin disease. If you take a drug that works in a model of cancer or model of arthritis in mice and give it to mice that have real cancer or real arthritis, it doesn’t work.

Furthermore, laboratory mice have been bred to be genetically identical, they ‘re kept in clean cages with filtered water and filter air, and they’re fed same diets. Basically, when you do an experiment on 20 mice, you’re doing the experiment on the same mouse 20 times. This is done for a good reason, namely so that results can be replicated, but it doesn’t translate well to people who live in heterogeneous environments, exposed to all kinds of pathogens, and eat varied diets.

Pets are different. They live in the same environment as us, exposed to similar variety of pathogenic insults, and until recently shared our diet. And that’s why almost all drugs that work in people work in pets and vice versa.

So a drug that extends lifespan in pets has a much higher likelihood of translating into a drug that extends lifespan in people. And if we can extend lifespan in pets, it means we have a good chance of doing the same in people.