Dog owners do many things to keep their companions happy and healthy. They could soon add an antiaging pill to their pooch’s regimen of walks, vet visits and belly rubs.
Loyal, a biotech start-up based in San Francisco, said Wednesday that a drug it developed to increase canine lifespan passed a significant milestone on the way to regulatory approval.
The Food and Drug Administration certified the daily pill as having a “reasonable expectation of effectiveness” at extending senior dogs’ lifespans.
The regulator’s Center for Veterinary Medicine still has to certify that the drug is safe and that Loyal can manufacture it at scale before vets can prescribe the pill to dogs 10 years or older who weigh 14 pounds or more.
While the drug’s cost to consumers is yet to be determined, Halioua said in a Zoom interview that she wants to make Loyal’s treatment accessible to as many dogs as possible, ideally for under $100 per month.
Read the full story: See Spot live longer: Antiaging pill for dogs clears key FDA hurdle
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5 Likes
KarlT
#2
I really want this to work and be a good thing, but I have serious doubts about the science behind it and the FDA approval was very suspect.
I’m not too worried about the science behind it. I believe its an IGF-1 lowering drug for larger dogs (at least the first drug they are focused on bringing out) and that science is well established, and Matt Kaeberlein and others are on the scientific advisory board, and they have an experienced team:
This isn’t a Theranos-type fraud.
2 Likes
WJ_PhD
#4
It is an IGF-1 lowering drug and the oral form is supposed to come out later in 2025 and cost <$100/month. Loyal is currently enrolling a large clinical trial as well. If you can wait, it might be better to have more data.
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Yes - higher levels of IGF-1 is the key reason for larger dogs, and the shorter lifespan of larger dogs:
2 Likes
KarlT
#6
My concern is that they didn’t actually show that the drugs will extend life. Just that it’s a reasonable expectation.
“The FDA’s Center for Veterinary Medicine has determined that Loyal’s data provides reasonable expectation of LOY-002’s intended effect of extending canine lifespan”
They are doing the studies…
This new RXE is the second to receive acceptance by the FDA for a longevity drug developed by Loyal. The first, LOY-001, received RXE acceptance in November 2023. LOY-001 is a prescription injection that targets large- and giant-breed dogs such as rottweilers, Great Danes and Bernese Mountain dogs, according to Celine Halioua, CEO of Loyal.2
A third longevity drug, LOY-003, is also in Loyal’s pipeline. LOY-003 is a prescription pill that aims to provide the same benefits to the large- and giant-breed canine population as LOY-001. Both LOY-001 and LOY-003 intend to target dogs aged 7 years and older, weighing at least 40 lbs.1
Clinical study
Loyal is currently running the STAY clinical study to further examine LOY-002, and to provide effectiveness and field safety data for its’ FDA application for drug approval. Launched in late 2023, the STAY study is expected to run 4 years with 1000 dogs enrolled at dozens of independent veterinary clinics across the US. Half of the enrolled dogs are receiving a beef-flavored LOY-002 pill while half of the study enrollees receive a placebo.3
In a dvm360 interview, Ellen Ratcliff, DVM, vice president of clinical and veterinary medicine at Loyal, said the study has been running in approximately 70 US veterinary clinics. Participation is being recorded in rural, urban and large metropolitan areas. “[It is] just a lot of really great engagement with veterinarians,” she said. “One of the neat things about the STAY study is that we are using a lot of clinical trial-naïve study sites—veterinarians who have never participated in clinical research or doing clinical research at their clinics.”
The STAY study dosed its’ first dog, a Whippet named Boo, in December 2023. This study is the first and only FDA-concurred clinical trial for longevity and is the largest veterinary trial in history, according to Loyal.1,3
“It doesn’t do anybody any good if their dog lives longer, but they live longer in that period at the end of the life where they don’t feel well, and they’re sick, having all kinds of degenerative and aging diseases. So, the STAY study is also measuring quality of life according to the owner and the owner assessment of the dog’s quality of life,” Ratcliff said.
And the Anti-aging pills for dogs is making news… see this video:
1 Like
AnUser
#9
This is very likely going to work and happy that there is a program like RXE acceptance to get potential therapies into customers hands earlier as long as it’s safe.
I’ll be using my pseudonym Fido Bark to get my supply …
I do wonder how many humans will end up seeking this out … I’m happy sitting back and watching.
3 Likes
Funny - yes, I saw Celine of Loyal, at the Longevity Summit and mentioned that people (on our website) would likely start taking this drug when it becomes available. She said the FDA actually required them to submit human information on the drug as part of their submission, probably because they suspected the same thing…
1 Like
AnUser
#12
What’s the substance called except LOY-002?
They have not revealed the details yet, but I suspect its a somatostatin analog like octreotide. Just like other somatostatin analogs they are starting with an injection-based medication, then developing a pill-based one.
1 Like
AnUser
#14
Does anyone know if the biomarker for efficacy is IGF-1?
Yes - that would be the most likely measure. You can’t really use growth hormone levels because they change too much hour to hour, day to day, but IGF-1 is more much slower to raise and lower and more reflective of longer term trends.
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AnUser
#16
Okay, we can lower IGF-1 in other ways than this drug then and which might already be FDA approved or generally considered safe like diet changes?
No situation like with finasteride and measuring DHT levels?
Not surprisingly Rapamycin/Sirolimus is a top choice for lowering IGF-1.
I use IGF-1 as a proxy for making sure individuals on HGH are not on too much - a mid %tile is likely fine as it is a proxy for Growth Hormone - at least the action of it, but also is bumped up by high protein diets, and is definitely linked to premature again and cancer when driven up.
2 Likes
AnUser
#18
Saw someone who’ve been on high meat, keto and carnivore diet, recently diagnosed with testicular cancer at a young age, but likely curable. That scared me slightly with slacking with diet in general and not forget the lack of data we have of some of these diets.
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