Loyal

Loyal is a veterinary therapeutics developer working on drugs aimed at the biology of aging in dogs rather than at individual age-associated diseases. The company frames aging as the most significant modifiable risk factor for many degenerative and chronic conditions in adult dogs, and targets the underlying processes that lead to age-associated disease and disability in order to extend healthy lifespan.

The company has three drug programs in development. Its lead candidate, LOY-002, is a once-daily pill for senior dogs aged 10 years and older weighing at least 14 pounds; it is intended to preserve quality of life and extend lifespan by improving metabolic health and insulin sensitivity and lowering insulin levels. LOY-002 is being evaluated in the STAY clinical trial, which spans 70 veterinary practices and has enrolled 1,317 dogs. Loyal is pursuing FDA conditional approval for LOY-002 and has had two of three major requirements accepted: preliminary efficacy data (RXE) and safety studies (TAS), with manufacturing (CMC) still in progress.

Alongside its drug programs, Loyal operates the Loyal Learning Hub, a free library of RACE-approved continuing education courses on canine aging for veterinary teams, and publishes senior dog care resources and clinical trial information for dog owners and veterinarians.

Traction

Three drug programs are in development. The STAY clinical trial for LOY-002 involves 70 veterinary practices and 1,317 enrolled dogs. LOY-002 has completed two of the three major requirements for FDA conditional approval, with the preliminary efficacy data package and safety studies accepted and manufacturing review in progress.

Latest developments

LOY-002 recently cleared the second of three major requirements for FDA conditional approval when its safety studies were accepted, leaving manufacturing (CMC) as the remaining component. The company states this is the clearest signal yet that a longevity drug for dogs could become available.