We’ve now fully enrolled our first clinical study for LOY-002 — the internal name for our daily tablet intended to extend lifespan and quality of life for older dogs. Sixty companion dogs — from 7 to 10 years old, and weighing from 14 to 180 pounds — are participating to help us better understand LOY-002’s impact on how dogs age.
Pilots and pivotals
To bring a new medicine to market, we must show the FDA that the drug is safe and effective, and a big part of doing this is running clinical trials — studies in companion dogs that demonstrate the real-world benefits of a new drug. In animal health, clinical trials fall into two categories: pilot studies and pivotal studies.
A pilot study — as the name suggests — is a smaller-scale study intended to test both the drug and the design and operational structure of the research. This is especially important for our upcoming pivotal clinical trial of LOY-002, as this is a first-in-class study, and likely one of the largest veterinary clinical trials ever run!
A core Loyal value is to learn by doing, and this requires humility. We’re doing many things for the first time — as a company and for the field as a whole — and we aren’t so bold as to believe that we’ll achieve perfection out of the box. Instead, we build in ways to test our assumptions and structures and iterate quickly. Running a pilot study gives us the opportunity to surface and address any potential issues in the logistics of our study, in addition to gathering valuable biological data.
This pilot study will help us ensure the success of our upcoming pivotal study — which recently received protocol concurrence from the FDA. The pivotal study will in turn gather the safety and efficacy data the FDA will use to assess LOY-002’s efficacy.
How pilot studies work
Our studies are run by independent veterinary clinics, and the study participants are dogs enrolled by their owners.
We wrote recently about our Healthspan study — an observational study that assessed tools for measuring frailty and health-related quality of life in dogs.
This LOY-002 pilot study is an interventional study, which means that it includes dosing of our drug. This is the first time dogs have received LOY-002 in a clinical setting.
Our main objective for this study is to observe how our drug affects biomarkers that change with age.
Enrolling clinical studies can be challenging — there are detailed requirements for a dog to qualify, and veterinarians are incredibly busy with the day-to-day rigors of running their clinics. It’s common for enrollment periods to be extended.
For this study, not only did we hit our enrollment goal of 60 dogs, we enrolled them on time, and at the rate necessary for our LOY-002 pivotal study — a great proof-of-concept of this ambitious study’s operational viability!
A team effort
We met this challenge thanks to the diligence of our clinical team, strong relationships with our study sites, and high engagement from dog owners.
We want to thank our three amazing clinical site partners and their staff for all their effort in bringing this study to life so quickly. We couldn’t have asked for better collaborators.
Our goal is to make participating in a Loyal clinical trial easy and enjoyable for sites and dog owners alike.
We’re actively recruiting veterinary practices across the country to partner with us on future clinical trials — including our LOY-002 pivotal later this year. To learn more, get in touch with our veterinary team today.
Thanks to our canine partners
Of course, a successful study wouldn’t be possible without the wonderful dogs who enrolled. We’d like to introduce three of our participants.
Meet Griffy, the 9-year-old Havanese — a breed known for their plumed tail and bouncing gait. He’s already a big contributor to our science, having also participated in our Healthspan study.
Josie is a 7-year-old Mastiff, and the first dog to ever take our drug as part of our clinical studies. Her owner reported that Josie loved the taste of our LOY-002 tablets.
Atlas is a friendly and energetic 9-year-old Pit Bull mix who participated in both our Healthspan study and this pilot study. We were delighted to welcome him back.
Are you a pet parent excited about making a difference and participating in our studies? Join the Loyal List, and be the first to know when we’re recruiting dogs for our pivotal study later this year.
Tennery is Loyal’s Clinical Operations Manager, bringing deep experience with clinical trials on both the site and sponsor sides.
Before Loyal, she worked as a Clinical Research Associate with canine and feline osteoarthritis studies, as a Clinical Trial Coordinator leading autologous immunotherapy studies for canine cancers, and as a Clinical Data Coordinator managing study data for human gynecological and head and neck cancers.
Tennery completed her BSc in Animal Science and Industries from Kansas State University. She enjoys spending time with her many reptiles and amphibians, her cat Kira, her dog Maisy, and her horse Scarlet.