The Zydus group will be making an oral presentation on Saroglitazar, a novel compound under development for treatment in non-alcoholic Steatohepatitis (NASH), at the Keystone Symposium on Liver Metabolism and Non-alcoholic Fatty Liver Disease (NAFLD) to be held from 22nd to 27th March, 2015 at Fairmont Chateau Whistler in Whistler, British Columbia.
Saroglitazar demonstrated good efficacy in animal models of NASH, along with associated biomarkers. It has reduced hepatic steatosis, ballooning, inflammation and fibrosis in liver. Further, the recently completed phase 2 studies of Saroglitazar in patients with biopsy proven nonalcoholic fatty liver disease, have shown improvement in both liver enzymes along with favorable effects on lipid and glycemic indices.
Speaking on the announcement, Pankaj R Patel, chairman and managing director, Zydus Cadila said, “There are currently no approved therapies to treat NASH. Saroglitazar is showing promise in NASH, and Zydus will continue further research to develop this important therapeutic for NASH patients.”
In addition to the oral presentation, the group will also be presenting a poster during the Poster Session 2 on 24th March 2015 at the conference.
Nonalcoholic steatohepatitis (NASH) is a liver disease in which fat accumulates in the liver. Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD which progresses to lethal NASH situation. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can lead to cirrhosis and liver failure. This is currently an unmet healthcare need as there are currently no drugs approved for the treatment of NASH and patients often have to undergo liver transplant to survive.
Lipaglyn (Saroglitazar) was launched in September 2013 in India, for treating hypertriglyceridemia and diabetic dyslipidemia in patients with type 2 diabetes not controlled by statins. Since then, more than 60000 patients are availing this drug with a prescriber base over 3000 diabetologists, cardiologists and physicians. Lipaglyn helps in a reduction of triglycerides and LDL (bad) cholesterol, along with an increase in HDL (good) cholesterol and has also shown a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c), thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients. With a non-renal route of elimination, Lipaglyn has no adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions. Lipaglyn can be taken only under the advice and guidance of a registered medical practitioner.