Loyal, a clinical-stage animal health company developing longevity drugs for dogs, announced that the FDA’s Center for Veterinary Medicine has accepted the Reasonable Expectation of Effectiveness (RXE) section of its conditional approval application for LOY-002.
This drug aims to extend the lifespan of senior dogs and maintain their quality of life as they age, building on the company’s previous RXE acceptance for a longevity drug specifically targeting the short lifespan of large-breed dogs.
The company also revealed it has raised a $22 million B-2 round from Valor Equity Partners and Collaborative Fund, and others, in addition to its $45 million Series B in 2024. This brings the total investment in Loyal’s to over $150 million. Jonathan Shulkin, Partner and Co-President at Valor Equity Partners, is joining the company’s Board of Directors.
The FDA’s Center for Veterinary Medicine determined that Loyal’s data provides reasonable expectation of LOY-002’s intended effect of extending canine lifespan, marking a significant milestone in the company’s pursuit of conditional approval.
LOY-002 is a daily flavored tablet developed for dogs aged 10 and older weighing at least 14 pounds, representing an approach to canine longevity by targeting metabolic dysfunction, one of the key underlying mechanisms of aging. And this preventive therapy aims to reduce the incidence and severity of age-associated diseases that diminish senior dogs’ quality of life, offering a practical alternative to established longevity interventions like caloric restriction.
The FDA’s acceptance of RXE showed confidence in Loyal’s innovative approach. The company anticipates completing the manufacturing and safety requirements for Expanded Conditional Approval (XCA) from the FDA by the end of the year.
Loyal is also running its clinical trial called the STAY study. The STAY study is LOY-002’s pivotal efficacy study that dosed its first dog in December 2023 and it will take place over approximately four years. It is the first and only FDA-concurred clinical trial for longevity and is the largest veterinary trial in history, recruiting over 1,000 dogs from 70 veterinary clinics across the country.
KEY QUOTES:
“Everything we do is in service of helping dogs live longer, healthier lives. These two milestones represent our ongoing commitment to that mission through years of diligence and hard work. Proving efficacy is one of the most challenging parts of developing a novel drug. While we still have significant work to do, RXE increases the probability that dogs will soon have access to our longevity drugs.”
- Loyal Founder and CEO Celine Halioua
“Loyal’s progress in bringing their products to market continues to impress, especially since they are breaking new regulatory ground.”
- Linda Rhodes, VMD, PhD, a veterinarian and experienced animal health executive who serves on Loyal’s Board of Directors
“Achieving RXE acceptance is a testament to the ongoing importance of the STAY study. Completing enrollment and seeing what the data shows over the next several years is critical, but this is an important step in the process. We now have validation from one of the highest quality regulatory agencies in the world that the drug we’re testing has a reasonable expectation of extending a dog’s life.”
- Ellen Ratcliff, VP of Clinical and Veterinary Medicine at Loyal
