Companies

Zydus gets positive results in clinical trials of Saroglitazar Magnesium for liver disease

Our Bureau Ahmedabad | Updated on October 02, 2019 Published on October 02, 2019

Zydus Cadila's manufacturing facility at Moraiya, Ahmedabad

The molecule has achieved primary end-points in the EVIDENCES IV trial in patients

Cadila Healthcare Ltd (Zydus Cadila) on Wednesday announced positive results from the EVIDENCES IV Phase 2 clinical trial of Saroglitazar Magnesium, for treatment of liver diseases like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic Steatohepatitis (NASH).

The investigational molecule undergoing clinical evaluation in the US, Saroglitazar Magnesium, has achieved the primary end-points in the EVIDENCES IV trial in patients with NAFLD and NASH, the company said in a statement here.

Considered a major breakthrough in the treatment of liver disease, the EVIDENCES IV NASH trial was a randomised, double-blind, placebo-controlled study that enrolled 106 patients with NAFLD, including NASH, across 20 clinical sites in the US.

"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," the statement said.

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.

Chalasani said, "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 among patients with NAFLD and NASH, for a drug that improves not just the liver disease, but important co-morbidities such as insulin resistance and dyslipidemia."

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, the statement added.

The secondary endpoints of the trial also included measurement 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 that have been conducted to assess the effect of Saroglitazar Magnesium in various populations with NAFLD, including patients with NASH.

Published on October 02, 2019
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