Cadila Healthcare (Zydus Cadilla) said that it has obtained permission from the US Food and Drug Administration (FDA) to launch the phase 2(b)/3 clinical trial of saroglitazar magnesium in primary biliary cholangitis (PBC).

The late-stage trial, designed to assess the efficacy and safety of saroglitazar magnesium, will have 192 patients. The participants will be randomly grouped in a 1:1:1 ratio to receive Saroglitazar 1 mg or Saroglitazar 2 mg or placebo.

The clinical trial will study saroglitazar magnesium (1 or 2 mg) in comparison to placebo based on the composite endpoints — Alkaline Phosphatase (ALP), liver stiffness measurement (LSM) by FibroScan, total bilirubin, liver enzyme parameters, lipid parameters, health related quality of life using PBC 40 questionnaire and other outcome measures over a 52-week period.

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% 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.”

Saroglitazar magnesium is an investigational compound that has orphan drug designation and fast track designation in the US for primary biliary cholangitis.

  Cadila Healthcare, Pankaj R. Patel, primary biliary cholangitis, Saroglitazar, saroglitazar magnesium, US FDA, USA, Zydus Cadilla