Zydus reports positive Phase II(b) EVIDENCES-X results for Saroglitazar Mg in MASH
Global trial met its primary endpoint of MASH resolution without worsening of fibrosis at week 52
Zydus Lifesciences (Zydus) has announced positive topline results from the completed EVIDENCES-X global Phase II(b) clinical trial evaluating the efficacy and safety of Saroglitazar Magnesium (Saroglitazar Mg) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.
The prospective, multicentre, randomised, double-blind, placebo-controlled 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 met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at week 52, with a treatment difference of 26.5 per cent.
The study also reported findings across key secondary and exploratory endpoints, including improvements in liver histology parameters and assessments of steatosis, inflammation and ballooning. Detailed results from the EVIDENCES-X trial will be presented at an upcoming Liver Congress and submitted for publication in a peer-reviewed medical journal.
The EVIDENCES-X trial was 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 global study enrolled patients across the United States, Turkey and Argentina.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said, “The successful completion of the EVIDENCES-X Phase II(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.”
Metabolic dysfunction Associated Steatotic Liver Disease (MASLD) and MASH continue to represent significant unmet medical needs globally. It is estimated that approximately 25 per cent of adults worldwide are affected by MASLD, while MASH affects an estimated 5 per cent to 20 per cent of the adult population.
MASH is characterised by hepatic steatosis, inflammation and hepatocellular injury and can progress to advanced fibrosis, cirrhosis, liver failure, hepatocellular carcinoma and death.
The results from EVIDENCES-X add to the evidence generated from earlier Phase II studies evaluating Saroglitazar in patients with MASH and MASLD and support the ongoing global development programme for Saroglitazar Mg in chronic liver diseases.
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 remains an investigational compound in the United States and has not been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH or MASLD.