Zydus Lifesciences Announces Positive Topline Results from EVIDENCES-X Phase II(b) MASH Trial
Zydus Lifesciences announced positive topline results from its EVIDENCES-X™ Phase II(b) MASH clinical trial. The trial met its primary endpoint, showing resolution of steatohepatitis with no worsening of fibrosis. This reinforces the therapeutic potential of Saroglitazar Mg for MASH patients.
Positive clinical trial results for a drug targeting a significant unmet medical need like MASH can have a medium-term impact on the company's future prospects and market position.
The announcement reports positive topline results from a clinical trial, indicating a successful outcome and progress in drug development.
Zydus Lifesciences Limited announced positive topline results from its completed EVIDENCES-X™ Phase II(b) clinical trial evaluating Saroglitazar Magnesium in patients with Metabolic dysfunction Associated Steatohepatitis (MASH) and fibrosis. The global, multicentre, randomized, double-blind, placebo-controlled study enrolled 189 subjects who received Saroglitazar 2 mg, Saroglitazar 4 mg, or placebo for 52 weeks.
The trial successfully achieved its primary endpoint, demonstrating a resolution of steatohepatitis with no worsening of fibrosis at week 52, with a treatment difference of 26.5%. The study also showed encouraging secondary outcomes, including improvements in liver histology, steatosis, inflammation, and ballooning assessments. These results add to the evidence supporting Saroglitazar Mg's therapeutic potential for MASH, a condition affecting millions globally with limited treatment options.
Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, stated that the successful completion of the trial is an important milestone and reinforces the therapeutic potential of Saroglitazar Mg. The company is committed to developing innovative treatments for chronic liver diseases. Data from the EVIDENCES-X™ trial will be presented at upcoming scientific meetings and submitted for publication. Saroglitazar Mg was approved in India in 2020 for MASH and MASLD and is an investigational compound in the United States.
A plain-language summary of a public exchange filing by Zydus Lifesciences Limited. Read the original for the full detail.