Zydus has announced positive topline results from its completed EVIDENCES-X phase 2(b), prospective, multicenter, randomised, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis.

The liver biopsy-driven EVIDENCES-X study enrolled 189 subjects who were randomised in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg or placebo over a treatment period of 52 weeks. The study successfully met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52 with the treatment difference of 26.5 percent.

In addition to achieving the primary endpoint, the study demonstrated encouraging findings across key secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation and ballooning assessments.

Further details would be presented in the upcoming Liver Congress.

The EVIDENCES-X trial was led by Professor Naga Chalasani, MD, Interim Chair, Department of Medicine, Indiana University School of Medicine, and Professor Arun J. Sanyal, M.D., Division of Gastroenterology, Virginia Commonwealth University, as co-Principal Investigators.

Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) and MASH, continue to represent significant unmet medical needs globally. Experts estimate that approximately 25 percent of adults worldwide are affected by MASLD, while MASH affects an estimated 5 percent to 20 percent of the adult population. MASH is characterised by hepatic steatosis, inflammation, and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure, liver cancer, and death.

Commenting on the positive outcome, Dr. Sharvil Patel, Managing Director (MD), Zydus Lifesciences, said, “The successful completion of the EVIDENCES-X phase 2(b) trial and achievement of the primary endpoint marks an important milestone in our MASH development programme. These results reinforce the therapeutic potential of Saroglitazar Mg and our commitment to developing innovative treatment options for patients suffering from chronic liver diseases.”

The positive results build upon previously published findings from earlier phase 2 studies of Saroglitazar in MASH and MASLD patients. Data from the EVIDENCES-X trial will be presented at upcoming scientific meetings and submitted for publication in a peer-reviewed medical journal. Saroglitazar Mg was approved by the Drug Controller General of India (DCGI), for the treatment of MASH and MASLD in India in 2020.

Saroglitazar Mg is an investigational compound in the US and has not yet been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH and MASLD.