Zydus Lifesciences has reported positive topline results from its global EVIDENCES-X Phase II(b) clinical trial evaluating Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis.

 

The 52-week, randomized, double-blind, placebo-controlled trial enrolled 189 patients across the US, Turkey and Argentina and met its primary endpoint — resolution of steatohepatitis without worsening of fibrosis.

 

The study recorded a 26.5% treatment difference on the primary endpoint at week 52, according to the company.

 

Beyond the primary endpoint, the trial also showed encouraging results across key secondary and exploratory measures, including liver histology, steatosis, inflammation and ballooning assessments.

 

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

 

Commenting on the results, 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.”

 

The latest results add to earlier Phase II data generated for Saroglitazar in patients with MASH and MASLD, strengthening Zydus’ ongoing development programme for the drug.

 

MASH is a progressive liver disease associated with metabolic dysfunction and is characterized by fat accumulation, inflammation and liver-cell injury. The condition can advance to fibrosis, cirrhosis, liver failure and liver cancer, creating a significant global health burden.

 

Zydus said approximately 25% of adults worldwide are affected by MASLD, while MASH is estimated to affect 5% to 20% of adults globally.

 

Saroglitazar Mg was approved by India’s Drug Controller General (DCGI) in 2020 for the treatment of MASH and MASLD. In the US, however, Saroglitazar Mg remains investigational and has not been approved by the US Food and Drug Administration or the European Medicines Agency for MASH or MASLD.

 

The EVIDENCES-X study evaluated two doses of Saroglitazar Mg — 2 mg and 4 mg — against placebo, with liver biopsy used to assess the primary endpoint after 52 weeks of treatment.