Aging is the most significant modifiable risk factor for most degenerative and chronic diseases in adult dogs. Targeting the ways dogs age and decline over time may be one of the most effective and practical ways for veterinarians to increase the healthy lifespan of their canine patients.
At Loyal, our approach is to help dogs live longer and stay healthier as they age by targeting the underlying processes that lead to age-associated disease and disability. Our drugs aim to extend lifespan and quality of life by reducing incidence or severity of age-related diseases.
LOY-002 is intended for dogs aged 10 or older and weighing at least 14 lb. It aims to extend healthy lifespan by targeting age-associated metabolic dysfunction.
As dogs age their metabolic health declines, leading to disease and reduced lifespan. Our aim with LOY-002 is to preserve metabolic health, which we believe will delay the onset of age-associated disease and help maintain better function and quality of life.
We’ve launched a double-blinded, placebo-controlled efficacy study recruiting 1,000 senior dogs in partnership with 55 veterinary clinics across the country. Learn more about the STAY study.
LOY-001 and LOY-003 are intended for dogs weighing 40 lb or more, and target the over-expression of IGF-1, a hormone that we believe is associated with large dogs’ shorter lifespan relative to small dogs.
Large body size in dogs is correlated with shortened lifespan, so the larger a breed is, the shorter the average longevity of dogs in that breed. We believe that sustained higher levels of Growth Hormone and IGF-1 in larger dogs are partly responsible for shorter lifespan and the earlier development of age-associated disease and disability. Our aim for LOY-001 and LOY-003 is to address this overexpression in adult dogs with the aim of reducing age-associated diseases and extending healthy lifespan.
LOY-001 is a prescription long-acting injection, while LOY-003 is a prescription daily pill. Learn more about these products for large dogs.
- Full safety data
- Full manufacturing data
- Reasonable expectation of effectiveness
In this study, we recruited dogs from across the United States from 2 to 18 years old, ranging from less than 15 to over 120 pounds. We analyzed 451 of these dogs to test how well the veterinary-assessed Canine Frailty Index and the owner-assessed Health-Related Quality of Life tool measured the effects of frailty and quality of life in both young and old dogs. Other endpoints included a thorough veterinary examination and blood marker measurements. This study has been published in a peer-reviewed journal.
Laboratory studies were used to identify the optimal dose of LOY-002 for future studies. Then studies were run to assess the ability of LOY-002 to impact age-associated biomarkers and confirm the dose for use in pilot studies and the pivotal effectiveness study. These studies provided the information that supports our application for Reasonable Expectation of Effectiveness (RXE) for LOY-002.
The safety of LOY-002 in dogs has been evaluated in a number of laboratory studies and a pilot clinical study. Over 400 dogs have received this drug in laboratory studies, including longitudinal studies of up to a year. The clinical study was performed at general practice veterinary clinics, 62 dogs were treated with either LOY-002 or control product, and the results have been included in our FDA submissions.
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 was especially important in preparation for our STAY study, which is likely one of the largest veterinary clinical trials ever run!
The STAY study is our pivotal efficacy study designed to demonstrate lifespan extension in senior dogs treated with LOY-002, a daily pill that aims to extend healthy lifespan in senior dogs of all but the smallest sizes. After this study’s conclusion, the data will be submitted to the FDA to support full approval.
Receiving a Reasonable Expectation of Effectiveness (RXE) technical section complete would mean that from our data, the FDA believes that LOY-002 is likely to be effective for dog lifespan extension in the real world.
The Target Animal Safety (TAS) technical section is an FDA submission that will present all safety information on the drug, and the FDA determines whether the drug is safe for the proposed use.
The Chemistry Manufacturing and Controls (CMC) technical section is an FDA submission that will demonstrate that LOY-002 can be manufactured consistently and safely, meeting all quality standards.
The FDA Center for Veterinary Medicine’s expanded conditional approval process allows companies to bring certain products to patients while conducting longer effectiveness studies, specifically when the product meets an important unmet need. This helps us get treatment as early as possible to older dogs who need it most. To receive conditional approval, the product must meet the same rigorous safety and manufacturing standards as drugs that are fully approved.
If the FDA CVM grants conditional approval for LOY-002, veterinarians will be able to prescribe the drug to qualified dogs as soon as 2025 while the STAY study continues to gather the lifespan data required for full approval.
veterinary professionals
For LOY-002, we have extensive data in over 400 dogs, including longitudinal studies of up to a year, and a pilot field study. We’ll be able to share this data as we get closer to launch.
For LOY-001 and LOY-003, we will submit full safety data as part of our application for expanded conditional approval (XCA). We’ll be able to disclose this data as we get closer to launching each product.
- For LOY-002, dogs 10 years and older and between 14 and 179 pounds
- For LOY-001 and LOY-003, dogs 7 years and older and at least 40 pounds
Clinical studies are designed to measure effectiveness among a target population, and for our lifespan extension drugs this means choosing a population that’s most likely to benefit over the duration of the study. If approved, our drugs will be labeled for use in the same populations studied in the clinical efficacy trials.
Our goal is to help as many dogs as possible, and we hope to pursue additional research to expand access to a broader population in the future.
LOY-002 aims to extend healthy lifespan by targeting age-associated metabolic dysfunction.
As dogs age their metabolic health declines, leading to disease and reduced lifespan. Our aim with LOY-002 is to preserve metabolic health, which we believe will delay the onset of age-associated disease and help maintain better function and quality of life.
LOY-001 and LOY-003 target the over-expression of IGF-1, a hormone that is associated with large dogs’ shorter lifespan relative to small dogs.
We believe that sustained higher levels of Growth Hormone and IGF-1 in large dogs are partly responsible for their shorter lifespan and the earlier development of age-associated disease and disability. Our goal for LOY-001 and LOY-003 is to address this overexpression in adult dogs with the aim of reducing age-associated diseases and extending healthy lifespan.
Our goal is to offer a range of options to suit the needs of veterinarians and dog owners.
A long-acting injection offers convenience and improved compliance, while a daily pill may be preferred by some owners.
We’ll be recruiting for our future studies soon. If you’re interested in being an investigator for our future clinical trials, send Dr. Mary Harrison a note at mary@loyal.com
At Loyal, we believe in transparency. We're currently in the FDA approval process, so we're limited on what we can share. As we (hopefully!) get closer to conditional approval, we can disclose more about our technical data and studies supporting safety and efficacy.
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