INDIANA, USA — It’s a cruel part of life that man’s best friend does not outlive us.
Even Bobi, the Rafeiro do Alentejo purebred who is the oldest living dog on record, lived about four decades shy of the global human life expectancy. But one company just got a little closer to putting a drug on store shelves that could put a dent in those dog years.
LOY-001 is an injectable drug that’s meant to extend the lifespan of large dogs and maintain their quality of life as they age, according to Loyal for Dogs, the biotech company based in San Francisco that developed the drug.
On Tuesday, the US Food and Drug Administration for Veterinary Medicine announced they approved the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application for LOY-001.
“Loyal has earned what we believe to be the FDA’s first-ever formal acceptance that a drug can be developed and approved to extend lifespan. In regulatory parlance, we have completed the technical effectiveness portion of our conditional approval application for LOY-001’s use in large dog lifespan extension”, wrote company founder Celine Halioua, who was named to the 2022 Forbes 30 Under 30 list, in a statement.
The drug is designed for larger dogs. While the average lifespan of a dog is 10 to 13 years according to the American Kennel Club, that varies a lot depending on breed. Smaller dog breeds like chihuahuas or miniature poodles could live for 20 years, while bigger pups like Great Danes only live 7-8 years on average.
It works by targeting the IGF-1, or insulin growth factor-1, hormone. Loyal claims their internal clinical trials, which have yet to be released publicly, found significantly higher levels of IGF-1 in large dog breeds, which they think accounts for why they don’t live as long as smaller breeds.
"The IGF-1 axis is one of the most well-studied longevity pathways. In model organisms from c.elegans to mice, reducing IGF-1 extends healthy lifespan, and increasing IGF-1 shortens healthy lifespan", the company said in a statement.
LOY-001 reduces the amount of IGF-1 in big dogs to levels seen in smaller-breed dogs, according to the company.
Dr. Melinda Anderson is a clinical assistant professor and veterinary pharmacist at Purdue University and said herself and other colleagues are excited about the possibility of the drug extending the life of large dog breeds, specifically on the impact it could have on people who use large breeds as service animals.
“These larger breed dogs, a lot of them are being used as service animals and that is huge for somebody who is dependent on their service dog to get them from one place to another or help them around the house. So, if we can expand longevity this could be fantastic,” Anderson said.
But since it’s still in the early stages of FDA approval, veterinary experts are eager to see their company’s clinical data before they officially endorse it. They think clinical data show more about the process they used to test the drug’s effectiveness.
Specifically, Anderson is interested in looking at what starting point the company used to bolster their claim that big dogs have 28 times more of the IGF-1 hormone than small breed dogs.
“Because the insulin growth factor is required for the growth of the musculoskeletal system, you know. The bones, the muscles, the skin. And as the dog is reaching puberty, those levels are climbing. And then at puberty, then they kind of plateau out and then kind of lower down. So, we'd be interested to know, at what point in the lifespan are they comparing those levels?” Anderson said.
Anderson told 13News would also be interested in seeing how they foresee, if that growth hormone is present to the extent the company says, what happens when you stop that.
“What is going to happen if we inhibit that in a large breed dog? If we inhibit that, what effect is that gonna have?” Anderson asked.
Large dog breeds often face a range of health issues late in life. However, not all of the life expectancy discrepancy between large and small dog breeds boils down to simple genetics or breeding. As larger dogs age, the wear and tear on their bodies becomes too much for some owners. Chronic illnesses can be easier to manage in smaller bodies pets, and Thomas said that can sometimes account for their lower life expectancy rates.
“It’s a strength commitment. It’s hard on the human body. It’s hard on their lifestyle and unfortunately that, too, contributes when looking at these statistics,” Anderson said.
If LOY-001 ever goes to market, dogs must weigh at least 40 pounds and be 7 years old in order to qualify. A shot would be administered every six months for qualifying dogs and is expected to be available in 2026, pending FDA approval of the company’s manufacturing and safety data, according to Loyal.
The company noted there was no established regulatory path for a lifespan extension drug, so they had to work with the FDA to find a way to demonstrate the efficacy of the aging drug. The process took more than four years, according to the company, and resulted in a 2,300-page technical section “now approved by the FDA”, the company said.
Thomas said veterinary companies having a hand in crafting their own approval process is sometimes necessary.
"The FDA is very accustomed to approving drugs on the human side. We deal with so many species, ranging from all of the exotics to our companion animals. So, there are some unique pathways and conversations that we need to have, and information we need to provide the FDA, that they're just not accustomed to dealing with," Anderson said.
As the drug awaits approval, owners of large breeds can take certain steps to help ensure their pet has a full and healthy life. Dr. Timea Brady sees thousands of animals yearly at Brownsburg Animal Clinic and said supplements and preventative measures can go a long way in lengthening your pet's life.
"The biggest thing is keeping them at a healthy weight. Then a good dog food, glucosamine supplements and fatty acid supplements can really help," Brady said.
Loyal's recent FDA hurdle comes as other projects across the country work to increase life-expectancy for canines. The Dog Aging Project out of the University of Washington is conducting clinical trials of the drug rapamycin, that has shown some promise in increasing the lifespan of mice.
Loyal is also now seeking volunteers for clinical trials that test a daily pill. The company did not respond to 13News' request for comment.
RELATED: Pets of the Week: 11-25-2023