December 22, 2023
About LabKey
The Big News
Loyal, a clinical-stage veterinary medicine company pioneering longevity research, recently hit a significant milestone in the pursuit of longevity for our canine companions. The FDA’s Center for Veterinary Medicine has granted approval for the Reasonable Expectation of Effectiveness section of Loyal’s conditional approval application for LOY-001, a groundbreaking drug designed to extend the lifespan of large dogs.
This achievement marks a pivotal shift in veterinary medicine. Both animal and human medicine traditionally address established diseases as they arise. In contrast, LOY-001 proactively targets aging mechanisms to prevent or delay age-associated conditions.
Once they complete the safety and manufacturing sections of their application and receive conditional approval, Loyal will be permitted to market LOY-001 for lifespan extension in the target canine population. This accelerated pathway is designed for drugs showing a reasonable expectation of effectiveness in addressing an unmet medical need.
The Treatment
LOY-001 operates by inhibiting insulin growth factor-1 (IGF-1), a growth-related hormone associated with aging in various animals.
Elevated IGF-1 levels have been observed in large dog breeds, who typically experience shorter life spans compared to smaller breeds. Loyal held an observational study featuring over 450 large dogs. In it, they uncovered a significant correlation: lower levels of this growth hormone were associated with reduced frailty and an improved quality of life.
This discovery led the FDA to recognize LOY-001’s potential capability of extending the lifespan of our four-legged friends. This approach isn’t just about longevity—it’s about enhancing the well-being of our furry pals as they age.
In parallel, Loyal is developing LOY-003, a daily pill focused on the same IGF-1 over-expression in large dogs, and LOY-002, a drug designed for senior dogs of nearly all sizes and focused on metabolic health.
LabKey Support for Loyal
Sample Manager plays a big role in advancing veterinary research for organizations like Loyal. The software streamlines research efforts with sample-centric freezer management, data-connected electronic lab notebook entries, workflow management, and extensive sample lineage histories. These tools facilitate the integration of samples with data, notebooks, and analysis.
Loyal uses Sample Manager to aid in organizing disparate sample sources from various collection sites and track these samples through testing and data analysis. Used this way, Sample Manager ensures the efficient and traceable collection of information necessary for regulatory approval.
Anticipating LOY-001’s pending full FDA approval, we look forward to seeing this drug potentially become available in 2026. This represents a significant stride in the fields of veterinary and longevity medicine.
