Zydus reveals positive data from EVIDENCES IV phase 2 clinical trial

Non-alcoholic Steatohepatitis (NASH) is a progressive disease which can ultimately lead to cirrhosis and liver failure. Liver transplantation is the only treatment for managing advanced cirrhosis with liver failure. There are currently no U.S. Food and Drug Administration (USFDA) approved treatments for NASH cirrhosis. Thus, researchers are coming up new with treatments that can treat this disease effectively.

Zydus Cadila is a global pharmaceutical company that has reportedly announced encouraging results from the EVIDENCES IV clinical trial of Saroglitazar Magnesium, an investigational molecule in U.S., undergoing clinical evaluation for treatment of liver diseases like NAFLD (Non-alcoholic fatty liver disease) with PCOS (polycystic ovary syndrome), Primary Biliary Cholangitis (PBC) and Nonalcoholic Steatohepatitis (NASH).

According to reports, Saroglitazar Magnesium achieved the primary endpoint in the EVIDENCES IV clinical trial, a double-blind, placebo-controlled, and randomized study that registered 106 patients with NAFLD comprising NASH across 20 U.S. based clinical sites.

Reportedly, for 16 Weeks; patients were randomly assigned in a ratio of 1:1:1:1 to receive the dose of 1mg, 2mg or 4mg or a matching placebo once in a day before breakfast in the morning.

Speaking on the trial, Prof. Naga P. Chalasani, MD and Associate Dean for Clinical Research and Director, Division of Gastroenterology & Hepatology, Indiana University School of Medicine, said that an authority in the areas of NAFLD and drug-induced liver injury was the lead Principal Investigator of the EVIDENCES IV trial.

Chalasani claims that 4mg dose of Saroglitazar had considerably improved liver biochemistries, insulin resistance, hepatic steatosis, dyslipidemia with zero weight gain or fluid retention. He added that these results were quite promising as there is a dire need for a drug that improves not only liver disease treatment but also is important co-morbidities such as dyslipidemia and insulin resistance.

Reliable sources cite that the study achieved primary endpoint in the EVIDENCES IV clinical trial when there was a percentage change in serum ALT levels at week 16, from baseline, in the Saroglitazar Magnesium groups comparing to the placebo group.

Source Credit - https://zyduscadila.com/public/pdf/pressrelease/Zydus_NASH_US_Press_Release.pdf