Celine Halioua, founder of Loyal.
Guerin Blask/The Forbes Collection
Celine Halioua’s company, Loyal, is getting ready to enter clinical trials for its new canine drug. Her goal? To give you more healthy, happy years with your dogs.
When Celine Halioua was named to the 2022 Forbes 30 Under 30 list, she told us that “There has never been a drug approved for aging for any species, dog or human. My core goal in life is to get the first drug approved.”
She’s now one step closer to her goal. On Friday, her company, Loyal announced that it has received a protocol concurrence from the FDA for a clinical trial of one of the longevity drugs that it has developed for dogs. If the clinical trial hits its desired endpoints, the drug could go to market as soon as 2025.
“We’re building this path to approving an aging drug for dogs,” Halioua, 28, says. “So that once somebody figures it out once, then it applies to others.”
The design of the study is relatively straightforward, says Karen Greenwood, senior vice president of regulatory and strategy for the company. The study, which the company aims to have underway by the end of the year, will have a control group and treatment group of demographically similar older dogs. And they’ll be evaluated for both their lifespans as well as a measure of their quality of life based on both veterinary criteria and the dog owners’ own observations.
The challenge the company had in working with the FDA (which also approves veterinary medicines) is that the regulatory body typically looks to approve drugs for diseases. But the two drugs that Loyal is working on aren’t aimed at disease but rather longevity–helping dogs live longer. So obtaining a protocol concurrence — a process where the FDA works with a private company to okay a study design where success is likely to lead to approval — took several rounds of discussions. That said, Greenwood says that her team had a “really fun time, with our statisticians having geeky conversations with their statisticians.”
“We really enjoy working with the FDA,” she continues. “They’re great scientists and so it’s always fun getting to take something new to them.”
Halioua founded Loyal in 2019 with an eye to dealing with one of the great tragedies of life: humans live a lot longer than their dogs. A part of the reason for this is the inbreeding that created and domesticated dogs in the first place, she says. But it’s possible that dogs could live longer than they do.
Studies backed by Purina, for example, found that calorie restricted diets to keep Labrador Retrievers lean not only increased their lifespan but also their quality of life. However, anyone who owns dogs knows that it’s nearly impossible for humans to resist giving them a treat. Or two. Or three.
What Loyal’s drugs aim to do, Halioua explains, is activate some of the same metabolic pathways that are activated by a calorie restricted diet. In theory, it could add years of healthy life to a dog. The clinical trials will put this theory to the test.
And she has believers. Since it was founded, Loyal has raised $58 million from venture investors such as Browder Capital, Khosla Ventures and other firms you might see typically backing more traditional enterprise software plays rather than a biotech company. But for Halioua, this is the kind of risk that Silicon Valley was made for.
“The thing that I think is interesting is this idea of doing really rigorous and really regulated science, and the idea of it being funded almost entirely by Silicon Valley VC money. We’re not a Boston biotech company,” she laughs, continuing on to say “It’s actually a very kind of old school Silicon Valley thing to bet on a big technical problem, and I think that has gotten lost over the last few years, but I don’t think Loyal could have started anywhere else.”
