Zydus randomises 'first patient' in phase 2 trial of Saroglitazar Mg in NASH
Ahmedabad: Zydus, a global pharmaceutical company has recently announced that the company has randomised the first patient into the Phase 2(b) Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled clinical trial to evaluate efficacy and safety of Saroglitazar Magnesium in subjects with Non-Alcoholic Steatohepatitis and Fibrosis.
Zydus had earlier received permission from the USFDA. The EVIDENCES-X liver biopsy driven Phase 2(b) trial will be led by Prof. Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine and Prof. Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University as co-Principal Investigators. The EVIDENCES-X trial will randomise 240 subjects in a 1:1:1 ratio to Saroglitazar 2 mg, Saroglitazar 4 mg or Placebo and study the primary endpoint
"Resolution of steatohepatitis with no worsening of fibrosis" over a period of 76 weeks. The secondary end-points will include improvement in liver fibrosis with no increase in NAS for ballooning, inflammation or steatosis, 2 points improvement in NAS, Improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy, Histological score changes in steatosis, ballooning, inflammation and fibrosis.
Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders. Experts estimate that about 25% of adults have NAFLD worldwide. NASH is a progressive form of NAFLD and is characterised by histologic evidence of hepatic steatosis, lobular inflammation, hepatocyte ballooning with or without pericellular fibrosis, and/or MalloryDenk bodies, which can progress to liver cirrhosis, liver cancer and need for liver transplant or death. Experts estimate about 5 – 20 % of adults worldwide have NASH placing significant clinical, economical, and health-related quality of life (HRQoL) burden for treating this liver disease. Analysts estimate the global market for Non-alcoholic steatohepatitis (NASH) treatment will reach $27 billion in 2029.
