Loyal, a clinical-stage animal health company developing longevity drugs for dogs, announced today that LOY-003, a pill designed to extend the lifespans of large dogs, completed the Reasonable Expectation of Effectiveness (RXE) section of its Expanded Conditional Approval (XCA) application.

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LOY-003, a daily pill aimed at extending the healthy lifespans of large- and giant-breed dogs, has met a key regulatory milestone.

LOY-003, a daily pill aimed at extending the healthy lifespans of large- and giant-breed dogs, has met a key regulatory milestone.

Since the FDA opened the XCA pathway to encourage novel drug development for unmet clinical needs in 2019, Loyal has created a new category of preventive medicines that target the root causes of aging. Now, the three lifespan extension drugs currently in Loyal’s portfolio have completed the efficacy requirements needed for XCA, a first for any pharma company.

“Bringing a drug through the FDA regulatory process is rigorous and complex,” said Loyal Founder and CEO Celine Halioua. “The agency sets and upholds standards that dog owners and veterinarians can trust, which is why we chose to pursue this path. Today’s milestone is another testament to the scientific approach we’re taking at Loyal to develop the first longevity drugs for dogs.”

A new approach to lifespan extension

While lifespan extension has been demonstrated in a number of species, including dogs, aging has traditionally not been considered a process that could be slowed or potentially treated.1 Loyal has pioneered the translation of this science into pharmaceutical drugs for dogs.

Loyal’s lead drug, LOY-002, targets insulin resistance as a driver of accelerated aging in senior dogs (10+). In addition to RXE, it has also completed the FDA’s Target Animal Safety section and is currently in its pivotal field study. The two other drugs in Loyal’s portfolio, LOY-001 and LOY-003, are focused on large dogs. These candidates target growth hormone (GH) and insulin-like growth factor-1 (IGF-1), two hormones that cause large and giant dogs to grow quickly but also lead to accelerated aging and shorter lifespans.

Loyal’s approach to directly targeting aging is unique. While other companies in the space focus on the diseases of aging, Loyal remains the only known company to work directly with the FDA on lifespan extension as a potential indication in any species. Beyond Loyal’s unique regulatory approach, the company continues to build out the research and clinical foundation for this novel class of drugs with the STAY study, LOY-002’s pivotal effectiveness trial, the first FDA-concurred interventional study for a lifespan extension drug.

With LOY-003’s RXE now complete, the three drugs currently in Loyal’s portfolio have now satisfied the efficacy requirement for XCA, a significant milestone towards bringing the first longevity drugs for dogs to market. If approved, Loyal’s lead drug program, LOY-002, is on track to be the first drug for lifespan extension in any species.

About Loyal

Loyal is an animal health company developing the first longevity drugs for dogs. With over $250M raised to date, Loyal hopes to extend the lifespan of dogs and improve their quality of life by targeting the underlying mechanisms of aging. Loyal’s work builds on decades of research, and their team of experts in dog health and longevity is dedicated to furthering this research and developing better ways to quantify and improve the aging process in dogs. It currently has three drugs in development and is making progress toward approval from the FDA’s Center for Veterinary Medicine.

For more information, please visit loyal.com.

References:

  1. Kealy RD, Lawler DF, Ballam JM, Mantz SL, Biery DN, Greeley EH, Lust G, Segre M, Smith GK, Stowe HD. Effects of diet restriction on life span and age-related changes in dogs. J Am Vet Med Assoc. 2002 May 1;220(9):1315-20. doi: 10.2460/javma.2002.220.1315. PMID: 11991408.

 

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