Zydus Lifesciences announced the successful completion of its EVIDENCES-X™ Phase II(b) clinical trial for Saroglitazar Mg, a potential treatment for Metabolic dysfunction Associated Steatohepatitis (MASH). The trial met its primary endpoint, showing resolution of steatohepatitis without worsening fibrosis. These positive topline results are a critical step in the ongoing development of this promising therapy for a significant unmet medical need.
Zydus Lifesciences Announces Positive Trial Results for MASH Treatment
Zydus Lifesciences Limited has announced the successful completion of its EVIDENCES-X™ global Phase II(b) clinical trial for Saroglitazar Mg, a treatment for Metabolic dysfunction Associated Steatohepatitis (MASH). The trial achieved its primary endpoint, demonstrating the resolution of steatohepatitis with no worsening of fibrosis, a significant advancement in the drug’s development for MASH.
EVIDENCES-X™ Trial Highlights
The prospective, multicentre, randomized, double-blind, placebo-controlled EVIDENCES-X™ trial evaluated the efficacy and safety of Saroglitazar Magnesium in patients with MASH and fibrosis. A total of 189 subjects were enrolled and randomized to receive either Saroglitazar 2 mg, Saroglitazar 4 mg, or a placebo over a 52-week treatment period. The study successfully met its primary endpoint, showing a 26.5% treatment difference in the resolution of steatohepatitis without worsening fibrosis at week 52. The trial also demonstrated encouraging secondary and exploratory endpoints, including improvements in liver histology parameters, steatosis, inflammation, and ballooning assessments. Further details are expected to be presented at an upcoming Liver Congress.
About MASH and Saroglitazar Mg
Metabolic dysfunction Associated Steatohepatitis (MASH) is a progressive liver disease affecting a significant portion of the global adult population, with an estimated 5% to 20% affected, and often progressing to more severe conditions like cirrhosis and liver failure. Saroglitazar Mg was approved by the Drug Controller General of India (DCGI) in 2020 for the treatment of MASH and MASLD in India. It is currently an investigational compound in the United States and has not yet received approval from the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMA).
Management Commentary
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, commented, “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 positive results build upon earlier Phase II studies of Saroglitazar in MASH and MASLD patients. Data from the EVIDENCES-X™ trial will be presented at scientific meetings and submitted for publication in a peer-reviewed medical journal.
Source: BSE
