Indian-based pharmaceutical company Zydus Cadila has secured approval from the US Food and Drug Administration (FDA) to conduct the Phase II clinical trial of saroglitazar in patients afflicted with non-alcoholic steatohepatitis (NASH) of the liver.
The randomised, double-blind Phase II trial will assess saroglitazar in dosage administrations of 1mg, 2mg and 4mg against placebo.
NASH describes a liver disease that fat deposits in the liver, which is caused by obesity and insulin resistance, as well as diabetes and lipid disorders.
It is said to be one of the leading causes of cirrhosis in the US and affects almost 6.5 million in the US and five major European countries.
Zydus Cadila chairman and managing director Pankaj Patel said: “NASH is an area of unmet healthcare need as there are currently no drugs approved for the treatment of NASH.
“Saroglitazar has a significant and differentiated effect on hepatic steatosis, whilst showing all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models.
“With a Phase III trial in biopsy proven NASH patients ongoing in India and a Phase II trial in NASH patients planned in USA, we are committed towards developing this drug for millions of patients suffering from NASH.”
To be conducted in several medical sites in the US, the trial will focus on areas including reduction in liver enzymes (serum ALT levels), liver stiffness (FibroScan), liver fat content via MRI-PDFF, cytokeratin-18 (CK-18), enhanced liver fibrosis (ELF), aspartate aminotransferase-to-platelet ratio index (APRI), lipids and insulin resistance, as well as glycemic control.
An earlier 52-week, Phase III clinical trial of saroglitazar in India has proven it is effective in animal models of NASH along with associated biomarkers, as it had resulted in reduced hepatic steatosis, ballooning, inflammation and fibrosis in liver.