Losing a beloved pet is a heartbreaking event, but soon that grief may be put on hold for dog owners, at least temporarily. A new drug is under development that could one day extend the lives of some large dog breeds.
LOY-001 was developed by a veterinary biotech company Loyal for Dogs. Although the drug has yet to undergo clinical trials, officials at the U.S. Food and Drug Administration (FDA) said in a letter to the company that initial data are "sufficient" to show a "reasonable expectation of efficacy," according to a copy of the letter provided to The The New York Times.
Celine Halioua, founder and CEO of Loyal, wrote in a Nov. 28 press release: “Today, I am extremely proud to announce that Loyal has obtained what we believe is the first formal approval from the FDA to allow the drug to be developed and approved for life extension.”
LOY-001 is the name of the first version of the drug, which is intended for dogs over 7 years old and weighing at least 40 pounds (about 18 kilograms). The drug is given as an injection that veterinarians can give to dogs every three to six months.
Scientists at Loyal are also simultaneously working on two other versions of the drug, called LOY-002 and LOY-003, which would be taken as daily pills. LOY-003 is designed for all senior dogs except the smallest breeds.
All versions of the drug work by limiting the strength of a growth hormone called insulin-like growth factor-1 (IGF-1), which promotes growth and is linked to aging and longevity in animals such as roundworms, fruit flies and mice.
Compared to smaller dogs like Chihuahuas, who live an average of 14 to 16 years, large dogs like Great Danes only live between 7 and 10 years.
Large dog breeds also have significantly higher levels of IGF-1 – up to 28 times higher than smaller dogs. In dogs, this hormone stimulates cell growth and is part of what allows large dog breeds to grow so large.
However, this hormone has serious disadvantages in old age. Although it is unlikely that a single hormone is responsible for all aging processes, it is one of the best-studied pathways in animal models and an avenue that deserves further investigation.
An unpublished observational study by Loyal that looked at the health of more than 450 large dogs found that dogs with lower insulin levels experienced less frailty and a better quality of life. Following these results and a review of more than 2,300 pages of Loyal's technical information, FDA officials confirmed LOY-001's potential to extend the lifespan of dogs.
With the concept validated, Halioua and her team now hope to receive conditional approval for LOY-001 by 2026. This would be an expedited FDA authorization that would allow the drug to come to market even as evidence is still being gathered from clinical trials.
