CymaBay Therapeutics (NASDAQ:CBAY) announces positive results from a Phase 3 clinical trial, ENHANCE, evaluating lead drug seladelpar in patients with primary biliary cholangitis (PBC), a chronic disease in which the liver’s bile ducts are slowly destroyed.
The study met the primary endpoint demonstrating a statistically significant responder rate compared to placebo. Specifically, 78.2% of the participants in the 10 mg arm and 57.1% of those in the 5 mg arm achieved the primary composite outcome versus 12.5% in the control arm.
The trial was terminated prior to completion of the 52-week treatment period so the primary endpoint was amended to a three-month time point prior to database lock.
In late November 2019, the FDA suspended all seladelpar studies after a potential safety signal was observed in a Phase 2b study. On July 23, it lifted all clinical holds after an investigation found no evidence of seladelpar-related liver injury.
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases with the lead indication being PBC.
Management hosted a conference call this morning at 8:00 am ET to discuss the results.
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