Cadila Healthcare Limited (Zydus Cadila) has received permission from the US Drug regulator, US Food and Drugs Administration (USFDA) to initiate the Phase 2(b)/3 clinical trials to evaluate the efficacy and the safety of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC).

PBC is a liver disease causing liver complications, which even leads to death in some cases. The EPICS-IIITM trial will randomise 192 subjects in a 1:1:1 ratio to Saroglitazar 1 mg, Saroglitazar 2 mg or Placebo and will study the Saroglitazar Magnesium (1 or 2 mg) relative to Placebo, Zydus said in a statement.

This will be a prospective, multi-centre, randomised, double-blind, placebo-controlled adaptive clinical trial to evaluate the efficacy and the safety of the drug.

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Speaking on the new development, Pankaj R Patel, Chairman of Cadila Healthcare, said, “Primary Biliary Cholangitis (PBC) is a severe liver disease leading to cirrhosis of the liver, liver failure, and possibly death. PBC patients have limited treatment options and approximately 50 per cent of the PBC patients are not able to benefit from the existing therapy due to lack of response or intolerable side effects. Based on the positive results from our earlier phase-2 study, we have now initiated the pivotal EPICS III trial in both cirrhotic and non-cirrhotic PBC patients.”

Composite endpoints

The study is based on the composite endpoints of Alkaline Phosphatase (ALP), total bilirubin, liver stiffness measurement (LSM) by FibroScan, liver enzyme parameters (ALT, AST, GGT, total bilirubin, and albumin), lipid parameters (TG, LDL-C, HDL-C, VLDL-C, total cholesterol and non-HDL-C), health related quality of life using PBC 40 questionnaire and other outcome measures over a period of 52 weeks, a statement said.

The EPICS-IIITM Phase 2(b)/3 trial will be led by Naga Chalasani, M.D., Interim Chair, Department of Medicine, Indiana University School of Medicine as principal investigator.

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The global market for PBC treatment is expected to grow at a CAGR of 36.3 per cent from 2018-2026, and is expected to reach $10.8 billion by 2026, as per Coherent market insights, the company stated.

Saroglitazar Mg is an investigational compound in the US, and is yet to be approved by the USFDA or thye European Medicines Agency (EMA). The USFDA has granted ‘Orphan Drug Designation’ and ‘Fast Track Designation’ to SaroglitazarMg for PBC. The European Medicines Agency (EMA) has designated “Saroglitazar Magnesium” with Orphan status for Treatment of Primary Biliary Cholangitis.