SAN FRANCISCO– Loyal, a biotech company pioneering longevity drugs for dogs, announced today that it has dosed the first dog in its STAY study, the pivotal clinical trial for its LOY-002 drug. LOY-002 is being developed by Loyal to extend the healthy lifespan of senior dogs and maintain their quality of life as they age.
The study is designed to provide pivotal effectiveness and field safety data in support of the company’s application for approval with the Food and Drug Administration (FDA). Loyal also is pursuing conditional approval for the drug, which would allow it to begin offering LOY-002 through veterinarians as soon as early 2025, while continuing to run this lifespan extension study in parallel.
The company recently announced a historic milestone in bringing its LOY-001 drug to market to extend lifespan in large-breed dogs. LOY-002 expands the canine population eligible for a Loyal product to senior dogs of all but the smallest sizes.
An 11-year-old Whippet named Boo is the first participating dog to be dosed in this study. His owner Deb Hanna enrolled him at Animal Hospital of Dauphin County (AHDC) in Harrisburg, Pennsylvania, where Dr. Coby Rudakewiz is our study investigator.
Despite his age, Boo still competes in a dog sport called scent work and loves having something to do. “That’s one of the reasons I enrolled him,” said 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.”
The STAY study will be the largest clinical study of its kind, conducted in partnership with more than 50 independent veterinary clinics and over 1,000 pet dogs, and is expected to last four years.
“The scale and complexity of STAY reflect Loyal’s commitment to creating demonstrably effective and safe products,” said Loyal CEO Celine Halioua. “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.”
To facilitate the development of future products, Loyal will also build a longitudinal biobank of saliva and blood samples from participating dogs to further support its research into improving longevity in dogs — and ultimately humans, too.
Participating veterinary clinics and animal hospitals across the country will begin enrolling dogs over the coming months.
“I’m genuinely excited to be able to share what we’ve seen as a life-changing product to dogs of all sizes,” said Dr. Rudakewiz. “This is what it’s all about — keeping dogs feeling their best to enjoy a long life with their owners who love them.”
LOY-002 is being developed to extend healthy lifespan by improving dogs’ metabolic health to delay the onset and reduce the impact of age-associated diseases.
The drug will be delivered as a daily pill, prescribed by veterinarians and designed for dogs 10 years or older and weighing at least 14 pounds.
Over the four-year span of STAY, the company will collect data on the drug’s potential impact on the lifespan and quality of life of dogs receiving LOY-002, compared to those receiving a placebo pill. The company will also collect data on any adverse effects among the study population. The results of the study will be shared with the FDA as part of Loyal’s application for full approval to market the drug for lifespan extension.
Based on the company’s existing efficacy, safety and manufacturing data, the company also is pursuing conditional approval for LOY-002. The FDA Center for Veterinary Medicine’s Expanded Conditional Approval pathway is an accelerated pathway for animal drugs that aims to increase the availability of innovative therapies. It’s designed for drugs that demonstrate a reasonable expectation of effectiveness in addressing an unmet medical need, but require complex and difficult studies to complete collection of definitive effectiveness data.
If the FDA grants conditional approval for LOY-002, veterinarians will be able to prescribe the drug to qualified dogs in early 2025 while the STAY study gathers the data required for full approval.
“There are more than 15 million senior dogs in the United States — including my much-loved senior Rottweiler, Della,” said Halioua. “The launch of this study brings us one step closer to helping senior dogs have more, healthier years with their families.”
