Loyal’s latest milestone: the first longevity clinical study design supported by the FDA
Some important news: Loyal has received protocol concurrence from the FDA on our companion dog longevity study. This means that the FDA has reviewed the scientific design of our study and determined that it meets their high quality standards, and will validate whether our drug extends canine lifespan and healthspan.
In other words, 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.
_________________________________________
Our concurrence means we fundamentally agree with your proposed design, execution, and analyses…
– FDA CENTER FOR VETERINARY MEDICINE
_________________________________________
This is a huge milestone for any drug company, but it’s especially significant because, to our knowledge, this is the first time the FDA has accepted a clinical study intending to show that a drug extends lifespan and healthspan, rather than only proving 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 we 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.
To achieve this milestone, we 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 interrogate and optimize our 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; both are paramount, scientifically and ethically.
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.
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.
What looks promising and effective in a laboratory must in turn be proven in the field — the real world, where dogs live alongside us, and under the supervision of veterinarians in a clinical setting. This is the purpose of clinical trials.
If the study doesn’t deliver a positive outcome, we won’t — and shouldn’t — get approval.
Designing a study to prove lifespan extension
Clinical studies are sometimes straightforward and sometimes complex. 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.
Ours has been a much longer process — a total of 553 days, just over 18 months, from first discussion on the program to protocol concurrence.
We believe we’re the first to design and receive FDA concurrence for a clinical study that measures lifespan extension following treatment of the underlying causes of aging, rather than any specific disease.
We’re 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.
→ Become a clinical trial site
Why FDA approval is so important
We often are asked why we aren’t working on dog aging supplements.
At Loyal we made the decision from the start that we would seek FDA approval for our 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.
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.
While supplements may not hurt and might help your dog, there’s no process to regulate or validate the claims they make on their label, so you can’t be sure of a supplement’s safety or effectiveness.
And for us, especially when our dogs are involved, that just isn’t good enough.
Be the first to know when we’re recruiting dogs for our study
→ Join our list today
Karen is Loyal’s Senior Vice President of Regulatory & Strategy, and brings more than three decades of animal pharmaceutical experience to the company. She spent 27 years in Pfizer’s Animal Health group and Zoetis before going on to oversee programs at leading animal pharmaceutical companies including Parnell and KindredBio.