Zydus Lifesciences has announced 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 company said the study successfully achieved its primary endpoint, marking an important milestone in its ongoing MASH development programme.
The EVIDENCES-X™ trial was a prospective, multicentre, randomized, double-blind and placebo-controlled study designed to assess the efficacy and safety of Saroglitazar Magnesium in patients with MASH and fibrosis. A total of 189 patients were enrolled in the study and randomly assigned in a 1:1:1 ratio to receive Saroglitazar 2 mg, Saroglitazar 4 mg or placebo.
Patients received treatment for 52 weeks, with the primary endpoint assessed through liver biopsy. According to Zydus, the trial met its primary endpoint of resolution of steatohepatitis with no worsening of fibrosis at Week 52, with a reported treatment difference of 26.5%.
In addition to the primary endpoint, the company reported encouraging findings across several secondary and exploratory measures. These included improvements in liver histology parameters, steatosis, inflammation and ballooning assessments. Zydus said more detailed findings from the study will be presented at an upcoming Liver Congress.
The global EVIDENCES-X™ study was conducted across the United States, Turkey and Argentina. The trial was led by Professor Naga Chalasani, M.D., Interim Chair, Department of Medicine at Indiana University School of Medicine, and Professor Arun J. Sanyal, M.D., Division of Gastroenterology at Virginia Commonwealth University, who served as co-Principal Investigators.
Commenting on the results, Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, said the successful completion of the Phase II(b) trial and achievement of the primary endpoint represents an important milestone for the company's MASH programme. He added that the findings reinforce the therapeutic potential of Saroglitazar Magnesium and Zydus' efforts to develop new treatment options for chronic liver diseases.
MASH is a progressive form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) in which fat accumulation in the liver is accompanied by inflammation and liver cell injury. The disease can progress to fibrosis, cirrhosis, liver failure and liver cancer, making it a significant global health concern.
According to Zydus, MASLD affects approximately 25% of adults worldwide, while MASH is estimated to affect around 5% to 20% of the adult population. Despite the growing disease burden, treatment options for MASH remain limited, increasing the need for effective therapies that can address both liver inflammation and disease progression.
The latest findings build on previously published clinical data from earlier Phase II studies of Saroglitazar in patients with MASH and MASLD. Zydus said data from the EVIDENCES-X™ study will be presented at upcoming scientific meetings and submitted for publication in a peer-reviewed medical journal.
Saroglitazar Magnesium received approval from India's Drug Controller General of India (DCGI) in 2020 for the treatment of MASH and MASLD in India. However, the drug remains investigational in the United States and has not been approved by either the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for the treatment of MASH or MASLD.
The positive Phase II(b) results are expected to contribute further evidence to Zydus' clinical development programme for Saroglitazar Magnesium as the company continues to evaluate its potential role in the treatment of MASH and other chronic liver diseases.
