Mirum Pharmaceuticals, Inc. presented new 28-week data from its Phase 2b VANTAGE study at the European Association for the Study of the Liver (EASL) meeting. The study is evaluating volixibat for cholestatic pruritus in patients with primary biliary cholangitis (PBC).
The data showed that volixibat treatment led to rapid and sustained reductions in ItchRO, with the combined dose group achieving a statistically significant 3.78-point reduction from Baseline (p<0.0001) and a placebo-adjusted response of 2.51 (p=0.0004). Additionally, 70% of volixibat-treated patients experienced a ≥50% reduction in serum bile acid levels.
Patients treated with volixibat also experienced improvements in fatigue and sleep, along with reductions in the inflammatory biomarker IL-31. The 20mg BID dose was selected for the confirmatory portion of the VANTAGE study, based on similar efficacy and safety profiles observed between the 20mg and 80mg doses.
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