A clinical trial is launched for a novel drug that could extend healthy lifespan in senior dogs

Boo, the first patient in the STAY clinical trial to receive a dose of LOY-002. (Photo courtesy of Loyal)

The first patient—an 11-year-old Whippet named Boo—has been dosed in a clinical trial for a developmental drug that aims to extend the healthy lifespan of senior dogs of most sizes. The LOY-002 product is being studied for use with the exception of the smallest senior canines by the startup biotech company Loyal.¹

“We are working to develop multiple dog longevity products,” said Celine Halioua, founder and CEO of Loyal, in an interview with dvm360. Notably, the company is also working to bring to market LOY-001, a longevity drug for large and giant breed dogs. LOY-001 received support from the FDA in November 2023, when the agency approved the Reasonable Expectation of Effectiveness section in Loyal’s application for conditional drug approval, following a review of clinical data, study results and scientific argument provided by the company.²

Loyal developed LOY-001 by first looking at the underlying mechanisms of aging. The drug works by reducing insulin-like growth factor 1 (IGF-1), a key biomarker hormone that drives cell growth and is believed to reduce the lifespan of large dogs.² 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.¹

“LOY-002 is a slightly different mechanism [than LOY-001] for senior lifespan extension. It’s a little bit more of a reversal mechanism. It’s not going to make a 10-year-old dog a puppy, but we’ve seen a rescuing in age-related functional decline in dogs that have been treated with this drug,” said Halioua, in the interview.

The new STAY study for LOY-002 is expected to last 4 years and include 1000 enrolled dogs, working in partnership with more than 50 independent veterinary clinics from across the country.¹ “It will be one of the largest veterinary clinical studies that, as far as we know, has ever been run,” said Halioua.

Boo was enrolled at the Animal Hospital of Dauphin County in Harrisburg, Pennsylvania, where Coby Rudakewiz, DVM, an associate veterinarian, is a STAY 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, in an organizational release.¹ “This is what it’s all about—keeping dogs feeling their best to enjoy a long life with their owners who love them.”

“The launch of this study brings us one step closer to helping senior dogs have more, healthier years with their families…The scale and complexity of STAY reflect Loyal’s commitment to creating demonstrably effective and safe products,” Halioua added in the release.¹ “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.”

The STAY study is designed to provide pivotal effectiveness and field safety data in support of the company’s application for FDA approval. The drug will be prescribed by veterinarians and administered as a daily beef-flavored pill to dogs age 10 years or older and weighing at least 14 pounds. Over the span of the study, Loyal 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, as well as any adverse effects reported in the study population. The study results will be shared with the FDA as part of the company’s application for full approval to market the drug for lifespan extension.¹

In the meantime, Loyal is also 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. LOY-001 is being anticipated by Loyal to be brought to the veterinary pharmaceutical market in 2026, pending appropriate approvals.^1,2

Loyal is also building a longitudinal biobank of saliva and blood samples from dogs participating in the STAY study. The biobank aims to facilitate the development of future products and further support the company’s research into improving longevity in dogs and, ultimately, in humans, too.¹

Despite his age, Boo still competes in a canine sport called "scent work" and seems to love having something stimulating to do. “That’s one of the reasons I enrolled him,” said Deb Hanna, Boo’s owner, in the release.¹ “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.”

Veterinary clinics and animal hospitals participating in the STAY study will begin enrolling additional dogs over the coming months. Dog owners interested in enrolling their senior dogs in STAY can learn more on the study’s website at https://loyalfordogs.com/clinical-trials.¹

References

1. Loyal launches nationwide, 1,000-dog clinical trial for drug to extend healthy lifespan in senior dogs. News release. Loyal. February 1, 2024
2. Coppock K. FDA determines drug for lifespan extension in large dogs to have a Reasonable Expectation of Effectiveness. dvm360. November 28, 2023. Accessed February 1, 2024. https://www.dvm360.com/view/fda-determines-drug-for-lifespan-extension-in-large-dogs-to-have-a-reasonable-expectation-of-effectiveness