Zydus plans filing following positive Phase IIb/III trial of saroglitazar in PPAR

India-based Zydus Lifesciences’ (BOM:532321) US subsidiary Zydus Therapeutic has announced positive top-line results from the pivotal EPICS-III Phase IIb/III clinical trial. In this trial, the safety and efficacy of saroglitazar, an investigational alpha/gamma peroxisome proliferator-activated receptor (PPAR) agonist.

The drug was evaluated for the treatment of adult patients with primary biliary cholangitis (PBC), a type of liver disease, who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard-of-care. The trial met the primary endpoint, with a statistically-significant treatment difference in the percentage of patients achieving a clinically meaningful biochemical response with #Saroglitazar compared to placebo.

The trial also met its key secondary endpoint, the proportion of subjects with complete normalization of ALP defined as ALP ≤ULN at 52 weeks. In the trial, Saroglitazar 1mg was generally well tolerated, with adverse events generally balanced between Saroglitazar 1mg-treated and placebo-treated patient. Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients.