Zydus Cadila to initiate global pivotal Phase 2(b)/3 clinical trial of Saroglitazar Mg in PBC

10 Dec 2021 Evaluate

Zydus Cadila has received permission from the U.S. Food and Drug Administration (USFDA) to initiate the Phase 2(b)/3 Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled adaptive clinical trial to evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (PBC).

The EPICS-III 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 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 (a patient-derived, disease specific quality of life measure developed and validated for use in PBC) and other outcome measures over a period of 52 weeks.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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