NEW DELHI: Drug firm Zydus Cadila said it has received approval from the US health regulator to initiate a phase II clinical trial of Saroglitazar in patients with non-alcoholic steatohepatitis (NASH) of the liver.
The company has received nod from the US Food and Drug Administration (USFDA) to conduct randomised, double-blind phase II trial to evaluate Saroglitazar in strengths of 1mg, 2mg and 4mg versus placebo, Zydus Cadila said in a statement.
“NASH is an area of unmet healthcare need as there are no drugs approved for the treatment of NASH. Saroglitazar has significant and differentiated effect on hepatic steatosis, while it shows all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models,” Zydus Cadila CMD Pankaj Patel said.
With a phase III trial in biopsy proven NASH patients ongoing in India and a phase II trial in NASH patients planned in USA, the company is committed towards developing this drug for millions of patients suffering from NASH, he added.
NASH is the area of significant unmet medical need in the US with an estimated 6.5 million adults in the country and five major European countries having advanced NASH.
NASH is a liver disease in which fat accumulates in the liver. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can progress to cirrhosis and liver failure. Liver transplantation is the only treatment for advanced cirrhosis with liver failure.
Biotech Analysts estimate the worldwide market for NASH medicines to reach USD 35-40 billion by 2025.