Cadila Healthcare gets FDA nod for phase 2(b)/3 trial of saroglitazar magnesium
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.