Our recent announcement about LOY-001 — our drug to extend healthy lifespan in large-breed dogs — prompted an incredible amount of press coverage and conversation, including a shoutout at the Emmy awards. We’ve been touched by how enthusiastic the response has been to our work.
With LOY-001’s focus on large dogs, one of the most frequent questions I’ve received is, “Where is the love for small dogs?!” The answer is: it’s here!
In parallel to the LOY-001 injectable for large dogs (and its daily-pill counterpart, LOY-003) we’ve been developing LOY-002, a daily pill designed to extend healthy lifespan in senior dogs of all but the smallest sizes.
Today, we’re announcing that we’ve dosed the first dog in our STAY study — our pivotal efficacy study to demonstrate lifespan extension in senior dogs treated with LOY-002. To our knowledge, no one in animal health has ever run such a long and diverse study, and we’ve received interest from a flood of owners and dog lovers who want their dog to take part.
Meet Boo, the first dog dosed in our study
An energetic 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 the STAY Principal Investigator.
Despite his age, Boo still competes in a dog sport called scent work — according to his owner he loves having something to do.
“That’s one of the reasons I enrolled him,” said Deb. “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 largest study of its kind
The STAY study will be conducted in partnership with more than 50 independent veterinary clinics like AHDC across the country, with over 1,000 pet dogs participating.
This is an unprecedented scale for a dog drug trial like this. For this study to definitively demonstrate that the LOY-002 extends healthy lifespan, we need sufficient diversity — breed, age, current health, behavior, geography, socioeconomics — among the study population.
Over 1,200 veterinarians have expressed interest in participating in STAY, in part because they respond to our mission to focus on the health of senior dogs.
“This was an easy decision,” said Dr. Rudakewiz. “At the AHDC, we are constantly looking for ways we can improve the way we care for pets and their health. The more avenues and tools we have to offer and educate owners on how to keep their dogs healthy, the more lives we can affect in a positive way.”
Over the four-year span of STAY, we’ll collect data on the drug’s impact on the lifespan of dogs receiving LOY-002 compared to those receiving placebo. We are also collecting data on quality of life and frailty. We’ll share the results of the study with the FDA as part of our application for full approval to market the drug for lifespan extension.
When will LOY-002 be available?
In parallel we’re also pursuing conditional approval for LOY-002 based on our existing efficacy, safety and manufacturing data. The FDA Center for Veterinary Medicine’s expanded conditional approval pathway is an accelerated approval program designed for animal drugs that address an unmet medical need, but require long or complex 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 as soon as early 2025 while the STAY study continues to gather the lifespan data required for full approval. We recently announced LOY-001 earning efficacy approval under this same program.
Enrolling your dog in STAY
Our first cohort of study sites has already begun enrolling senior dogs, and we’ll be bringing other sites online in the coming months.
If your dog meets the study criteria and you’re interested in enrolling them, visit the STAY page to look for sites near you.
Thank you to our partners
STAY is a massive undertaking that wouldn’t be possible without the partnership of the many veterinary teams running the study in their clinics, and the dogs and owners participating across the country — including you, Boo.
Thank you all for helping us bring these therapies to dogs everywhere.