A Multiple Dose, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Subcutaneously Administered BAZ- 2402 in Horses with Equine Metabolic Syndrome
Principal Investigator: Callum Donnelly
DESCRIPTION (provided by applicant):
Trodusquemine is an endogenous compound discovered in the liver of the dogfish shark. Trodusquemine reverses age-related processes both at the cellular level, and in vivo in worms, zebrafish, rodents, dogs, horses, and humans. In animal models of cancer, it replenishes the components of the immune system most vulnerable to aging, such as CD8+, CD4+, NK and dendritic cells, stimulates the activation and killing capacity of CD8+ cells and prevents the growth of tumors, as well as their ability to metastasize. In animal models of Alzheimer’s disease, it prevents neuronal loss, reduces β-amyloid and tau protein toxicity and inflammation, restores memory, and extends healthy lifespan. In horses and humans with the metabolic syndrome, it induces weight loss, reverses liver inflammation, systemic inflammatory markers, and normalizes insulin and glucose.
Safety of a single dose of synthetic Trodusquemine in horses has previously been determined, with no adverse events recorded. In this study horses with Equine Metabolic Syndrome (EMS) will receive repeated doses of synthetic Trodusquemine subcutaneously. Horses will be monitored over a three-month period for weight loss, improvement in insulin regulation and detection of adverse drug events. This study will be conducted across three centers with masked placebo control.