San Francisco Chronicle - (Sunday)
Startup making drug to extend dogs’ lives
A San Francisco-based biotechnology firm is on a mission to keep your best friend around a little longer.
Loyal is spearheading the development of an experimental drug geared toward extending the lifespan of large-breed dogs by a minimum of one year. On Tuesday, it secured conditional approval for its medication from the U.S. Food and Drug Administration.
The landmark approval clears the way for more extensive clinical trials. It also marks the first time the agency has endorsed a longevity drug.
Celine Halioua, the founder and CEO of Loyal, envisions making the proprietary drug, known by the generic moniker LOY-001, available to consumers — and their pooches — by 2026. In a blog post on Tuesday, she detailed the formidable challenges in getting the initial nod from the FDA.
“As there was no established regulatory path for a lifespan extension drug, we had to design from scratch a scientifically strong and logistically feasible way to demonstrate efficacy of an aging drug,” she wrote. “This process took more than four years, resulting in the 2,300+ page technical section now approved by the FDA.”
In a letter to Loyal, the FDA asserted that the drug, following a preliminary study, holds a “reasonable expectation of effectiveness.” This endorsement, regarded by Halioua as the biggest hurdle to getting LOY-001 on the market, does not conclusively establish the drug’s ability to extend the lives of dogs.
“To receive conditional approval, the product must meet the same rigorous safety and manufacturing standards as drugs that are fully approved,” Halioua said. “To stay on the market beyond the five-year conditional approval period, we must demonstrate full efficacy — in our case lifespan extension — in a pivotal study.”
Administered as an injection every three to six months by veterinarians, LOY-001 seeks to diminish
levels of the growth hormone IGF-1. Breeding dogs for size may lead to higher levels of IGF-1, which can potentially shorten their lifespan. Large dogs can have up to 28 times more of the hormone than small dogs.
The drug, which exhibited a side effect of mild gastrointestinal distress in early trials, is now poised for a larger study involving 1,000 large and giant breed companion dogs that are at least 7 years old.
The aging process in dogs is unique, with smaller breeds typically enjoying a longer lifespan than their larger counterparts — sometimes twice as many years. For example, Chihuahuas typically live between 12 and 20 years, whereas Great Danes have an average life expectancy of eight to 10 years.
Loyal’s ultimate goals extend beyond mere longevity. The company
wants its drugs to enhance canine well-being by mitigating vulnerability to age-related ailments such as cancer, arthritis, muscle atrophy, cognitive decline and neurodegeneration.
“Once we satisfactorily complete safety and manufacturing sections and other requirements, vets will be able to prescribe LOY-001 to extend the lifespan of large dogs while we complete the confirmatory pivotal lifespan extension study in parallel,” said Halioua, a scientist who founded Loyal in 2019. The 58-person company, a unit of Cellular Longevity, Inc., is based in the MidMarket area and backed by $60 million in venture capital from firms including Khosla Ventures, First Round and Box Group.
Simultaneously, Loyal is recruiting a clinical trial for LOY-002, targeting older dogs of diverse sizes and breeds, and
LOY-003, a daily pill variant of LOY-001. Halioua said she is committed to ensuring affordability and accessibility and intends to maintain a pricing structure for LOY-001 in the double digits per dosage.
Loyal’s breakthrough in canine longevity is part of a broader landscape of promising developments for dog enthusiasts.
Researchers at UC Davis last month published a study spotlighting the gene ERBB4 as a potential driver of dog longevity. Focused on Golden Retrievers, which are genetically predisposed to cancer, the study found that dogs with specific ERBB4 — also known as HER4 — variants survived an average of 13.5 years, in contrast to 11.6 years for others.
“Almost two years is a significant difference in a dog’s life,” said Danika Bannasch, a veterinary geneticist who specializes in canine genetics and co-author of the study, in a statement. “Wouldn’t we all want our beloved pets to live another two years? Two years in goldens is about a 15%-20% increase in lifespan, the equivalent of 12-14 years in humans.”
The implications of such canine studies may catalyze breakthroughs for humans in the long run.
“If we find that this variant in HER4 is important either in the formation or progression of cancer in Golden Retrievers or if it can actually modify a cancer risk in this cancer-predisposed population, that may be something that can be used in future cancer studies in humans,” said Robert Rebhun, corresponding author of the study.