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LOY-001 Clears FDA Hurdle, Aiming to Extend Lifespan of Large Dog Breeds

• LOY-001, an injectable drug by Loyal for Dogs, has received FDA acceptance for its effectiveness in potentially extending the lifespan of large dog breeds. • The drug targets the IGF-1 hormone, which Loyal's research suggests is linked to shorter lifespans in larger dogs compared to smaller breeds. • If approved, LOY-001 would be administered every six months to dogs weighing at least 40 pounds and aged 7 years or older, with potential availability by 2026. • Veterinary experts are awaiting the release of Loyal's clinical data to fully assess the drug's efficacy and potential long-term effects on canine health.

San Francisco, CA – Loyal for Dogs, a biotech company, has achieved a significant milestone with its drug LOY-001, designed to extend the lifespan and maintain the quality of life for aging large dog breeds. The FDA has approved the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application, marking a crucial step toward potential market availability by 2026.

Targeting IGF-1 for Longevity

LOY-001 is an injectable drug that targets the insulin growth factor-1 (IGF-1) hormone. According to Loyal, internal clinical trials indicate that larger dog breeds have significantly higher levels of IGF-1 compared to smaller breeds, which may contribute to their shorter lifespans. The company posits that reducing IGF-1 levels in large dogs to those observed in smaller breeds could extend their healthy lifespan.
"The IGF-1 axis is one of the most well-studied longevity pathways. In model organisms from c.elegans to mice, reducing IGF-1 extends healthy lifespan, and increasing IGF-1 shortens healthy lifespan," the company stated.

Clinical and Veterinary Perspectives

Dr. Melinda Anderson, a clinical assistant professor and veterinary pharmacist at Purdue University, expressed enthusiasm about the potential benefits of LOY-001, particularly for service animals. "These larger breed dogs, a lot of them are being used as service animals and that is huge for somebody who is dependent on their service dog to get them from one place to another or help them around the house. So, if we can expand longevity this could be fantastic," Anderson said.
However, veterinary experts are keen to review Loyal's clinical data to fully evaluate the drug's effectiveness and potential impacts. Anderson is particularly interested in understanding the baseline IGF-1 levels used for comparison and the potential effects of inhibiting IGF-1 in large breed dogs.

Considerations for Large Breed Health

Large dog breeds often experience a higher incidence of age-related health issues, contributing to their shorter lifespans, which average 7-8 years compared to the 10-13 years seen in average for all dogs. Factors beyond genetics, such as the physical strain on larger bodies and the challenges of managing chronic illnesses in larger pets, also play a role.

Eligibility and Administration

If LOY-001 receives full FDA approval, it will be available for dogs weighing at least 40 pounds and aged 7 years or older. The drug is administered via injection every six months. Loyal had to collaborate with the FDA to create a novel approval pathway for a lifespan extension drug, resulting in a 2,300-page technical section.

Ongoing Research and Preventative Care

Other initiatives, such as the Dog Aging Project at the University of Washington, are also exploring methods to extend canine lifespan, including clinical trials of rapamycin. Meanwhile, veterinarians emphasize the importance of maintaining a healthy weight, providing a good diet, and using supplements like glucosamine and fatty acids to support the health and longevity of large breed dogs.
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