Loyal announces the first longevity clinical study design supported by FDA

Leaders from Loyal, a biotech startup working to extend dogs’ health span and lifespan, announced on March 10 at SXSW that the U.S. Food and Drug Administration (FDA) granted protocol concurrence for the company’s companion dog longevity study. 

In a blog post and news release, Loyal’s regulatory expert Karen Greenwood weighed in on what this means for the company, for the field of aging and for dogs everywhere.

Greenwood said that the FDA’s decision means the company’s scientific design of the study meets high quality standards and will validate whether Loyal’s drug extends canine lifespan and health span.

“If our study demonstrates that our dog longevity drug extends healthy lifespan, those results will be sufficient to support bringing the drug to market for dogs across the country,” she wrote

Greenwood said this is a huge milestone for any drug company, but it’s especially significant because, based on her knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and health span. This compares with a requirement to only prove efficacy against a single, specific disease, which is the case with most drugs on the market today.

Loyal was founded around the audacious idea that pets should have drugs explicitly designed and FDA-approved to extend general healthy lifespan. “With this milestone we take another big step in the direction of this vision,” she said. 

Greenwood said the Loyal team worked with scientists and statisticians at the Center for Veterinary Medicine (CVM), the division of the FDA responsible for overseeing the medicines we give our pets, to optimize the study design.

“We and the CVM have a shared interest in making sure our study is designed in a way that proves whether our products are effective and safe,” she said. “Both are paramount, scientifically and ethically.”

The regulatory expert cautioned that protocol concurrence is a huge step, but it’s not a guarantee.

“While we’re energized by this milestone, there’s still a lot of hard and careful work to be done,” she said. “Clinical trials are complex, and although we strive always to make scientific, evidence-based decisions in our study design and treatments, we won’t actually know how a drug will perform at scale in the real world until we run the study,” Greenwood said. 

What looks promising and effective in a laboratory must in turn be proven in the field, in the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. 

Greenwood said that if the study doesn’t deliver a positive outcome, the company won’t — and shouldn’t — get approval. 

Designing a study to prove longevity extension 

Clinical studies are sometimes straightforward and sometimes complex, according to the blog post. A study to show whether a new flea and tick treatment works can take much less time to design and conduct, since there are many previous studies showing how to measure the efficacy of these drugs.

Loyal’s journey so far has been a much longer process — a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.

The company is actively recruiting veterinary practices across the country to run clinical trials later this year. If you’re interested in partnering with us on this groundbreaking study, get in touch with our veterinary team today.

Why FDA approval is so important 

Greenwood said company leaders often are asked why they aren’t working on dog aging supplements.

At Loyal, she said, the team made the decision from the start to seek FDA approval for its aging drugs. 

“It’s a rigorous, expensive, years-long process that sets a very high bar for both safety and efficacy — exactly as it should be,” she said. 

Supplements have no such obligation, and even if they do run their own studies, there’s no oversight. This is why you’ll see a “These statements have not been evaluated by the FDA” disclaimer in fine print on supplements for dogs and humans alike.

Greenwood said that from the company’s perspective, especially when our dogs are involved, that just isn’t good enough.

Karen Greenwood is Loyal’s senior vice president of Regulatory & Strategy and brings more than three decades of animal pharmaceutical experience to the company. She spent many years in Pfizer’s Animal Health group and Zoetis before going on to oversee programs at leading animal pharmaceutical companies including Parnell and KindredBio.

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