Metabolic syndrome such as Type II diabetes and fat liver diseases are typically associated with hepatic lipid accumulation, inflammatory responses, and apoptosis and/or necrosis. Endogenous regulatory oxysterol sulfates, 5-cholesten-3,25-diol 3-sulfate (25HC3S) and 5-cholesten-3,25-diol 3,25-disulfate (25HCDS) have been shown to modulate gene expression that decrease lipid accumulation, suppress inflammatory responses, and block cell death. The lead molecule, 25HC3S, has demonstrated positive effects in multiple animal models, decreasing serum and hepatic lipid accumulation, reducing hepatocyte ballooning and fibrosis, minimizing hepatocellular nodule formation, and increasing glucose tolerance and insulin sensitivity in high fat diet mouse models. Additionally, in LPS- and acetaminophen-induced acute organ injury mouse models, 25HC3S attenuated multi-organ injury and increased survival rate. 25HC3S has been administered orally, intramuscularly (IM), or intravenously (IV) to more than 140 human subjects in various Phase 1 and Phase 1b trials, and was well tolerated at exposures several thousand-fold higher than endogenous levels. A Phase 1b study in liver function impaired patients has shown that a single oral dose of 25HC3S significantly decreased biomarkers of cell death and inflammation, as well as serum bilirubin levels. These results suggest that 25HC3S has the potential to treat chronic and acute liver diseases, including metabolic syndrome and type II diabetes.

Shunlin Ren, Professor at Virginia Commonwealth University and Senior Member of National Academy of Inventors, USA. He received his Medical Degree from Shanghai First Medical College (Current Fudan Shanghai Medical College), and his Ph.D degree from Virginia Commonwealth University. He is a principal investigator. His research has been supported by NIH R01 and VA Merit Review grants, Research Career Scientist Award, American Liver Scholar Award, and Durect Corporation Research Agreement. He has published more than 50 papers in reputed journals and 55 US and World patents and patent application. He is serving as an editorial board member of repute.  His research has focused on the role of oxysterols and oxysterol sulfation in lipid metabolism, inflammatory responses, and cell proliferation.