India, Aug. 29 -- Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., has announced positive topline results from its pivotal EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis (PBC) who had an inadequate response or intolerance to the standard-of-care, ursodeoxycholic acid (UDCA).
The study met its primary endpoint, with Saroglitazar 1mg showing a 48.5% higher rate of biochemical response compared to placebo (P<0.001). It also achieved the key secondary endpoint of complete ALP normalization at 52 weeks. Both ALP and bilirubin are critical markers of PBC progression. The drug was generally well tolerated, with adverse events comparable to placebo.
Zydus said it int...