First dog dosed in study designed to demonstrate lifespan and healthspan extension in 1,000 senior dogs.
Longevity biotech company Loyal has initiated a clinical trial in the US for a drug designed to extend the healthy lifespan of senior dogs. The pivotal STAY study, involving over 1,000 dogs, is key to Loyal’s pursuit of FDA approval for its “LOY-002” canine medication.
The company made waves last year by getting the nod from the FDA for LOY-001, its drug to extend healthy lifespan in large dogs, which even prompted a shoutout at the recent Emmy Awards. With LOY-002, Loyal is expanding the eligible canine population to include senior dogs of all but the smallest sizes.
The drug, delivered as a daily beef-flavored pill, targets metabolic health to mitigate age-associated diseases in dogs aged 10 or older, weighing at least 14 pounds. Loyal’s goal is to delay the onset and reduce the impact of such diseases, ultimately improving the overall quality of life for senior dogs.
The STAY study, expected to span four years, is set to be the largest clinical trial of its kind, conducted in collaboration with more than 50 independent veterinary clinics.
“This is a massive undertaking that wouldn’t be possible without the partnership of the many veterinarians and technicians operating the study in their clinics, and the participating dogs and owners helping advance therapies for all dogs,” said Loyal CEO Celine Halioua.
Based on existing efficacy, safety and manufacturing data, Loyal is also pursuing FDA “conditional approval” for LOY-002, with the aim of making the drug available through veterinarians as early as 2025.
A model for aging in humans
As part of the STAY trial, Loyal plans to establish a longitudinal biobank comprising saliva and blood samples from participating dogs, bolstering its research efforts to improve longevity not only in dogs but also in humans. Halioua told us that while the company’s priority is helping as many dogs as possible, dogs are also an “excellent model for aging in humans.”
“We live in the same environments and share similar lifestyles,” she said. “We face similar age-associated diseases for the same reasons. Because of this we hope to someday be able to translate what we learn about longevity in dogs into similar therapies for humans.”
The first participant in the STAY study, an 11-year-old Whippet named Boo, received the initial dose at the Animal Hospital of Dauphin County in Harrisburg, Pennsylvania, where Dr Coby Rudakewiz is the study investigator.
“I’m genuinely excited to be able to share what we’ve seen as a life-changing product to dogs of all sizes,” said Rudakewiz. “This is what it’s all about – keeping dogs feeling their best to enjoy a long life with their owners who love them.”
Despite his advanced age, Boo still competes in a dog sport known as “scent work.”
“That’s one of the reasons I enrolled him,” said owner Deb Hanna. “It could help other dogs, including my younger dogs someday. It’s very important. I think anybody that has an older dog that could participate would jump at the chance.”