On Tuesday morning, biotech company Loyal announced that it had reached a key milestone in the path toward approval of its lifespan-extending drug for big dogs.
The announcement came after the Food and Drug Administration (FDA) Center for Veterinary Medicine confirmed that Loyal’s data (all 2,300 pages of it, according to CEO Celine Halioua) met a key requirement for the FDA’s fast-track conditional approval pathway for animal therapies – reasonable expectation of effectiveness. This means that the FDA is satisfied that the drug, LOY-001 is likely to be effective at increasing the lifespan of large dogs.
Although the company is still required to produce safety and manufacturing data for LOY-001, if conditional approval is given, the drug would be allowed to be marketed for canine life extension whilst it awaits full approval. It’s hoped that LOY-001 could be launched as early as 2026, pending approval.
“Loyal was founded with the ambitious goal of developing the first drugs to extend healthy lifespan in dogs,” said Halioua in a statement. “This milestone is the result of years of careful work by the team. We’ll continue to work just as diligently to bring this and our other longevity programs through to FDA approval.”
Big and giant dogs, such as golden retrievers, Great Danes and Newfoundlands tend to have notoriously short lifespans – the latter have an average life expectancy of eight to 10 years. Previous research has suggested that this is the result of years of selective breeding for big dogs, giving them the genetic recipe for huge bodies, but also short lives.
“The extreme phenotypic variety found in dogs is not ‘natural’ – it’s the result of intensive breeding by humans to create dogs that excelled at tasks such as herding, protection, and companionship,” said Brennen McKenzie, Loyal’s Director of Veterinary Medicine. “At Loyal, we see the short lifespan of big dogs not as inevitable, but as a genetically-associated disease caused by historical artificial selection, and therefore amenable to targeting and treatment with a drug.”
LOY-001’s target? The growth hormone IGF-1, which is believed to be present in elevated levels in large dogs. Designed to be injected every three to six months, LOY-001 aims to reduce the level of IGF-1 to that seen in smaller dogs, which often have longer lifespans. The FDA’s agreement that Loyal’s data supports “reasonable expectation of effectiveness” suggested that aim is likely to be met.
This doesn’t mean that dogs could live infinitely though, however sad that truth may be. “These are definitely not immortality or radical life-span-extension drugs,” said Halioua in an email sent to the New York Times. “Nothing we are developing could make a dog live forever.”
It does, however, provide some hope that our canine companions could live a little longer, and hopefully, have a better quality of life whilst doing so. It may also mark an important step in the development of longevity drugs in general – if it meets FDA standards, LOY-001 would be the first ever lifespan-extension drug to be approved.
Only time and research will tell if life-extending drug development and approval will extend beyond dogs, but that certainly hasn’t stopped some humans from attempting… unique ways to combat aging.