In a groundbreaking development, the San Francisco-based biotech firm Loyal has announced a significant milestone in the journey toward FDA approval of its canine anti-aging drug. The drug, known as LOY-001, has successfully cleared the initial hurdles necessary for regulatory endorsement, marking a pivotal moment in the pursuit of longevity-enhancing treatments not just for dogs but potentially for humans as well, according to a report by Hilary Brueck for Business Insider.

LOY-001 is primarily designed for dogs aged 7 years and older, weighing a minimum of 18 kilograms. It’s administered as an injectable treatment every three to six months by veterinarians.

While the drug still awaits rigorous clinical trials, this achievement represents a remarkable shift in the FDA’s stance toward longevity-enhancing medications. Researchers and scientists have long sought ways to slow down the aging process and extend the lifespan of various species. Recent breakthroughs in scientific studies include the extension of roundworm lifespans by a staggering 500 percent through genetic modifications. Earlier this year, scientists made headlines by reportedly reversing signs of aging in mice.

However, the quest to combat aging in more complex and long-lived creatures, like humans, has proven to be a challenging endeavor. The prolonged timespan required for clinical trials, which could span decades before yielding meaningful data, presents a substantial financial hurdle. Nevertheless, Loyal’s CEO, Celine Halioua, believes that dogs, which experience age-related ailments around the same time in their lives as humans, could serve as a valuable model for researching longevity-enhancing treatments.

Halioua explains, “If a big dog is, you know, getting sick and dying from age-related diseases at age seven, eight, nine, he’s going gray at age four. He’s getting a limp at age five… The rate of aging is so high that you can tell if a drug is impacting that in about 6 to 12 months. In 6 to 12 months, you’re not going to see anything in a person.”

LOY-001, Loyal’s groundbreaking drug, is administered through injections and specifically targets a growth and metabolism hormone known as IGF-1. This hormone’s levels vary in accordance with the size of the dog, being higher in larger breeds and lower in smaller ones. Previous research has indicated that inhibiting IGF-1 in flies, worms, and rodents can significantly extend their lifespans, as reported by Wired’s Emily Mullin. However, canine longevity is influenced by multiple factors beyond just this hormone.

Designed for healthy dogs over the age of seven and weighing above 40 pounds, LOY-001 would be administered every three to six months by a veterinarian. In parallel, Loyal is also working on developing a daily pill known as LOY-003.

Halioua clarifies, “We’re not making immortal dogs, to be clear, but that rate of aging will be slower, hopefully, which means the pet will be in a healthier state for longer. And that’s fundamental to all of the biology of what we’re doing.”

It’s important to note that manipulating the aging process in animals raises significant ethical questions, particularly concerning the quality of life for these animals.

Kate Creevy, a veterinarian at Texas A&M University and the chief veterinary officer of the Dog Aging Project, which is conducting trials on a different anti-aging drug for dogs called rapamycin, expresses her concerns, stating, “If it proves true that it extends lifespan, I’m only interested in that if the period of life that is extended is good quality life. I don’t want to make my dog live an extra two years in poor health.”

Loyal argues that humans have been inadvertently influencing the aging process in dogs for years through selective breeding, which may have contributed to the accelerated aging observed in larger dog breeds.

The company has ambitious plans ahead, aiming to initiate a large-scale clinical trial for LOY-001 involving approximately 1,000 large and giant dogs, with a targeted launch of the product on the market by 2026, expected to commence in either 2024 or 2025.

How does the drug work?

Larger dogs tend to exhibit significantly higher levels of a growth hormone known as insulin growth factor-1 (IGF-1), with concentrations up to 28 times greater than those found in smaller breeds. This hormone plays a crucial role in cell growth, contributing to the larger size of these breeds.

However, as these dogs age, high levels of IGF-1 may pose detrimental effects. Although it’s understood that no single hormone is solely responsible for aging, IGF-1’s impact on the aging process is a well-researched area in animal studies and is considered a key factor to investigate further.

Loyal, a veterinary biotech company, conducted an observational study involving over 450 large dogs. This study, which remains unpublished, revealed that dogs with lower levels of insulin experienced less frailty and an overall better quality of life.

These findings, along with an extensive review of more than 2,300 pages of technical data from Loyal, led officials at the U.S. Food and Drug Administration (FDA) to acknowledge the potential of LOY-001, a drug developed by Loyal, in extending the lifespans of larger dogs.

Loyal isnow aiming for conditional approval of LOY-001 by 2026. This expedited authorization process by the FDA would allow the drug to be released to the market even as ongoing clinical trials continue to gather further evidence. This step could mark a significant advancement in enhancing the health and longevity of large dog breeds.

What’s next in the pipeline?

Loyal’s research team is also advancing the development of two other drug formulations, LOY-002 and LOY-003, which would be available as daily oral medications. LOY-003 is specifically tailored for older dogs, excluding the smallest breeds.

These drugs operate by inhibiting the action of a growth hormone known as insulin growth factor-1 (IGF-1), linked to aging and longevity in various animal species. This hormone is notably higher in larger dog breeds, which typically have shorter lifespans compared to smaller breeds. For instance, while a Chihuahua may live up to 14-16 years, a Great Dane often has a lifespan of just 7-10 years.

An exploratory study by Loyal involving over 450 large dogs suggested that lower insulin levels in these animals correlate with reduced frailty and improved quality of life. This observation, coupled with extensive technical data from the company, led the FDA to recognize the promise of LOY-001 in extending the lives of larger dogs.

Loyal’s next goal, as stated by Halioua, is to secure conditional approval for LOY-001 by 2026. This expedited FDA authorization would allow the drug to be marketed while further clinical trial data is gathered, potentially revolutionizing the field of canine health and longevity.

Having said that, IGF-1 is only just one factor thought to be linked to dog longevity. In a recent study published last month, scientists at UC Davis have identified a gene called ERBB4 that was found to play a crucial role in extending the lifespan of golden retrievers. Danika Bannasch, the lead scientist of that study, said that Loyal’s drug will still need to clear a high safety bar before being approved by the FDA for dog owners. “As a pet owner, I think anything over a year would be great. I suspect people would be really interested in that,” she told wired magazine.

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