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Loyal's LOY-001 Receives FDA's Nod for Potential Lifespan Extension in Large Dogs

• Loyal's LOY-001 has received FDA agreement on its potential effectiveness in extending lifespan of large dog breeds, marking a significant milestone. • The drug targets insulin growth factor-1 (IGF-1), a hormone linked to accelerated aging in larger dogs, aiming to improve their quality of life. • LOY-001 is designed as a vet-administered injection given every 3-6 months, with potential market availability as early as 2026 after further trials. • Clinical trials are ongoing, and Loyal is also developing alternative formulations, including daily pills, to cater to different dog sizes and owner preferences.

San Francisco-based biotech company Loyal has achieved a crucial milestone in its quest to extend the lifespan of large dog breeds. The Food and Drug Administration (FDA) has indicated that initial data for Loyal's drug, LOY-001, demonstrates a reasonable expectation of effectiveness in prolonging the lives of dogs weighing over 40 pounds and aged 7 years or older. This decision marks the first time the FDA has formally accepted that a drug can be developed and approved to extend lifespan.

Targeting IGF-1 for Longevity

LOY-001 works by modulating the activity of insulin growth factor-1 (IGF-1), a hormone that plays a significant role in growth and aging. Larger dog breeds often have elevated levels of IGF-1, which contributes to their rapid growth but is also believed to accelerate aging. By reducing IGF-1 levels in adult dogs, LOY-001 aims to slow down the aging process and extend their healthy years.
Celine Halioua, CEO of Loyal, explained that selectively breeding dogs for size has inadvertently led to increased IGF-1 levels, reducing their lifespan. Large dogs can have up to 28 times the IGF-1 levels of small dogs. LOY-001 is designed to counteract this effect, potentially leveling the playing field for larger breeds.

Clinical Development and Future Availability

LOY-001 is administered as an injection by a veterinarian every three to six months. Loyal is also developing two other versions, LOY-002 and LOY-003, which are designed as daily pills. LOY-003 is intended for all older dogs except the smallest breeds.
Following the FDA's feedback, Loyal hopes to secure conditional approval for LOY-001 by 2026. This accelerated approval pathway would allow the drug to be marketed while further efficacy data is collected from ongoing clinical trials. Halioua stated that the company is aiming for clinical trials to demonstrate at least a one-year extension in lifespan.

Considerations for Quality of Life

While the prospect of extending dog lifespans is exciting, experts emphasize the importance of maintaining quality of life. Kate Creevy, chief veterinary officer of the Dog Aging Project, stressed that any life extension should ensure that the added years are healthy and fulfilling.
Loyal is currently recruiting over a thousand senior dogs for clinical trials starting in 2024/2025 to further evaluate the drug's effectiveness and safety. The company aims to make the drug accessible to a wide range of pet owners, with a pricing strategy that reflects this goal.

Broader Implications for Longevity Research

The development of LOY-001 has implications beyond canine health. Research into the mechanisms of aging in dogs could provide valuable insights into human aging as well. The Dog Aging Project, for example, is also studying rapamycin, a drug with anti-aging effects in other species, as a potential life-extending treatment for dogs. These efforts could pave the way for future therapies targeting age-related diseases in both animals and humans.
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