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Loyal's Anti-Aging Drug for Senior Dogs Enters Clinical Trials, Aims to Extend Healthy Lifespan

• Loyal's LOY-002, a novel anti-aging drug targeting metabolic health in senior dogs, has entered clinical trials, potentially extending their healthy lifespan. • The STAY study, involving over 1,000 dogs across 50+ vet clinics, will assess LOY-002's impact on lifespan and quality of life compared to a placebo over four years. • LOY-002 aims to delay the onset and reduce the impact of age-associated diseases by improving metabolic fitness in older dogs. • Loyal anticipates conditional FDA approval for LOY-002 by early 2025, with plans to launch LOY-001, a longevity drug for large breeds, in 2026.

Loyal, a biotech startup, has launched clinical trials for LOY-002, an innovative drug designed to extend the healthy lifespan of senior dogs. The drug aims to improve metabolic health and delay age-related diseases, potentially offering a significant advancement in veterinary medicine and providing insights applicable to human aging research.

Targeting Metabolic Health in Aging Dogs

LOY-002 focuses on improving dogs' metabolic health to mitigate the effects of aging. As dogs age, their metabolism changes, leading to reduced health and increased susceptibility to age-related diseases. By targeting the underlying mechanisms of aging, Loyal hopes to extend the lifespan of dogs and maintain their quality of life as they age. Celine Halioua, founder and CEO of Loyal, explained that LOY-002 is designed as a "reversal mechanism" to rescue age-related functional decline in dogs.

The STAY Study: A Large-Scale Clinical Trial

The pivotal STAY study will enroll over 1,000 dogs aged 10 years and older, weighing at least 14 pounds, across more than 50 independent veterinary clinics in the United States. This four-year study will evaluate the effectiveness and safety of LOY-002 compared to a placebo. Participating dogs will receive a daily beef-flavored pill, and researchers will collect data on the drug's impact on lifespan, quality of life, and any potential adverse effects. According to Loyal, this is one of the largest veterinary clinical studies ever conducted.

LOY-001: Addressing Size-Related Longevity

In addition to LOY-002, Loyal is developing LOY-001, an injectable drug for large and giant breed dogs. LOY-001 targets the insulin-like growth factor 1 (IGF-1) hormone, which is believed to contribute to the shorter lifespan of larger breeds. By lowering IGF-1 levels, LOY-001 aims to slow the aging process and reduce the risk of age-related diseases such as cardiovascular disease, dementia, cancer, and metabolic disease. The FDA has already approved the Reasonable Expectation of Effectiveness section in Loyal’s application for conditional approval of LOY-001.

Implications for Veterinary and Human Medicine

The development of anti-aging drugs for dogs has broader implications for both veterinary and human medicine. Dogs share many of the same genes and can be diagnosed with similar diseases as humans, making them valuable models for aging research. Carmen Castaneda Sceppa, dean of Bouvé College of Health Sciences at Northeastern University, noted that this research could further our understanding of human metabolism and its impact on health and aging. Moreover, the establishment of a longitudinal biobank of samples from participating dogs will facilitate future research into improving longevity in both dogs and humans.

Conditional Approval and Future Availability

Loyal anticipates receiving conditional FDA approval for LOY-002 by early 2025, which would allow the drug to be prescribed by veterinarians while the STAY study continues. The company expects to launch LOY-001 in 2026, pending full regulatory approvals. These developments represent a significant step forward in extending the healthy lifespan of dogs and potentially paving the way for similar interventions in human aging.
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