icon-folder.gif   Conference Reports for NATAP  
  The Liver Meeting
Boston MA
November 2019
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Zydus Announces Positive Results From EVIDENCES IV Phase 2
Clinical Trial of Saroglitazar Magnesium in NAFLD and NASH

  Published: Oct 03, 2019
• EVIDENCES IV trial meets primary efficacy end-points
• Statistically significant 44.39 % reduction in ALT (alanine aminotransferase) observed with Saroglitazar Magnesium treated patients

AHMEDABAD, India, Oct. 3, 2019 /PRNewswire/ -- Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that Saroglitazar Magnesium has achieved the primary end-points in the EVIDENCES IV trial in patients with NAFLD and NASH.
The EVIDENCES IV NASH trial was a randomized, double-blind, placebo-controlled study that enrolled 106 patients with Non-Alcoholic Fatty Liver Disease (NAFLD), including Non-Alcoholic Steatohepatitis (NASH) across 20 clinical sites in the United States of America. Patients were randomly assigned in a ratio of 1:1:1:1 to receive Saroglitazar Magnesium 1mg or 2 mg or 4 mg or matching placebo once daily in the morning before breakfast for 16 Weeks.
Prof. Naga P. Chalasani, MD, Associate Dean for Clinical Research and Director, Division of Gastroenterology & Hepatology, Indiana University School of Medicine, USA, an authority in the fields of NAFLD and drug induced liver injury (DILI), was the lead Principal Investigator of the EVIDENCES IV trial. Prof. Chalasani stated, "Saroglitazar 4 mg significantly improved liver biochemistries, hepatic steatosis, dyslipidemia, and insulin resistance, with no weight gain or fluid retention. These results are quite encouraging as there is a significant unmet need for patients with NAFLD and NASH for a drug that improves not just the liver disease, but important comorbidities such as insulin resistance and dyslipidemia."
Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, "We are happy with the positive results that Saroglitazar Magnesium has shown in the EVIDENCES IV trial. We look forward to presenting the detailed data in upcoming scientific conferences and publishing the study findings in peer-reviewed scientific journals." The primary endpoint of the study was percentage change from baseline in serum ALT levels at Week 16 in the Saroglitazar Magnesium groups as compared to the placebo group. There was a statistically significant reduction in mean ALT from baseline to week 16 observed with all doses of Saroglitazar as compared to placebo.
A statistically significant reduction in hepatic fat content from baseline was observed in patients treated with Saroglitazar Magnesium as compared to placebo following 16 weeks of treatment as measured by MRI-PDFF. The secondary endpoints of the trial also included measurements of other Liver enzymes, Insulin resistance, Liver fibrosis, BMI, Waist circumference, MRI-derived measures of total liver fat index, Lipid and lipoprotein levels, and pharmacokinetic parameters.
This study is one of several EVIDENCES trials conducted to assess the effect of Saroglitazar Magnesium in various populations with NAFLD, including patients with NASH.
About NASH
NASH is the area of significant unmet medical need, with an estimated 6.5 million adults in the United States and five major European countries having advanced NASH. NASH is a progressive disease of the liver. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. NASH ranks as one of the major causes of cirrhosis in America, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure. There are currently no treatments approved by the U.S. Food and Drug Administration (USFDA) for treatment of NASH.
About Saroglitazar Magnesium
Saroglitazar Magnesium is an investigational molecule in USA, undergoing clinical evaluation for treatment of liver diseases like NAFLD with polycystic ovary syndrome (PCOS), Nonalcoholic Steatohepatitis (NASH) and Primary Biliary Cholangitis (PBC). Nonclinical studies have demonstrated that Saroglitazar, because of its unique mechanism of engaging PPAR alpha and PPAR gamma, favorably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis.
About Zydus
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs over 24,000 people worldwide, including 1400 scientists engaged in R & D, and is dedicated to creating healthier communities globally. www.zyduscadila.com
SOURCE Zydus Cadila
excerpted from NASH Debrief by Kathleen Corey MD