Zydus Cadila begins EVIDENCES-X phase 2b NASH trial of Saroglitazar Mg

Zydus Cadila (Cadila Healthcare) has dosed the first patient in the EVIDENCES-X phase 2b clinical trial of Saroglitazar Magnesium (Saroglitazar Mg) in non-alcoholic steatohepatitis (NASH).

The multi-centre, randomized, double-blind, placebo-controlled trial will assess the safety and efficacy of Saroglitazar Magnesium in patients with NASH and fibrosis.

The EVIDENCES-X clinical trial will randomly group 240 patients in a 1:1:1 ratio to be administered with Saroglitazar 2mg, Saroglitazar 4mg, or placebo.

The primary endpoint of the phase 2b Nash clinical trial is “resolution of steatohepatitis with no worsening of fibrosis” over a period of 76 weeks.

According to Zydus Cadila, the secondary end-points of the mid-stage clinical trial are improvement in liver fibrosis with no increase in NASH for ballooning, inflammation or steatosis, two points improvement in NASH, improvement in steatosis, ballooning, inflammation and fibrosis from liver biopsy, and histological score changes in steatosis, ballooning, inflammation and fibrosis.

Pankaj R. Patel — Chairman of Cadila Healthcare said: “As there is currently no drug approved for the treatment of NASH in the USA, this life threatening liver disease is a high unmet medical need. We are committed to develop novel therapeutics for patients living with liver diseases and fibrosis.”

Saroglitazar Mg is an investigational compound in the US, which has an orphan drug designation and fast track designation from the US Food and Drug Administration (FDA) has granted ‘to Saroglitazar Mg for primary biliary cholangitis (PBC). The compound has also been designated orphan status by the European Medicines Agency (EMA) for the same indication.