Company founder says FDA has formally accepted that a drug can be developed and approved to extend lifespan.
In a blog post this week, Celine Halioua, the founder and CEO of dog longevity biotech Loyal, revealed that the company has received what it believes to be the FDA’s “first-ever formal acceptance that a drug can be developed and approved to extend lifespan.” It appears the FDA has acknowledged the data presented by Loyal as part of the company’s conditional approval application for the use of its lead drug program (LOY-001) to extend lifespan in large dogs.
The absence of an established regulatory path for lifespan extension drugs prompted Loyal to design a scientifically robust and logistically feasible approach to demonstrate the efficacy of its drugs. This process, spanning more than four years, culminated in a 2,300+ page technical section now approved by the FDA.
“Our interventional studies with LOY-001 showed that the drug improved clinically-relevant aging parameters,” said Halioua. “From our data, the FDA believes LOY-001 is likely to be effective for large dog lifespan extension in the real world.”
Large and giant-breed dogs typically have significantly shorter lifespans than their smaller counterparts, characterized by Halioua as an “accelerated aging disorder.” Loyal’s approach addresses the underlying genetic factors contributing to the accelerated aging and reduced lifespan of these animals. LOY-001 operates by reducing elevated levels of IGF-1, a hormone linked to accelerated aging in large dogs. In addition to the injectable LOY-001, Loyal is developing a daily pill (LOY-003), in partnership with Crinetics, which also targets the overexpression of IGF-1.
The FDA’s conditional approval process provides an opportunity for Loyal to bring its drugs to market sooner. The expedited pathway will allow the company to conduct longer effectiveness studies while ensuring the safety and manufacturing standards required for full approval.
“This process will make it possible for us to bring our products into veterinary clinics everywhere, and lead the charge on a new approach to age-related disease and decline,” finished Halioua. “That will ultimately mean more healthy years for the dogs we love — and that’s why we’re here.”