magicmine/iStock via Getty Images Mirum Pharmaceuticals ( NASDAQ: MIRM ) shares climbed over 15% on Monday after it announced interim results from two phase 2b studies evaluating volixibat, its oral ileal bile acid transporter inhibitor. Volixibat is currently being evaluated in Phase 2b studies for two chronic liver diseases that affect the bile ducts, namely primary sclerosing cholangitis (PSC) (VISTAS study), and primary biliary cholangitis (PBC) (VANTAGE study). Interim results from the VANTAGE study evaluating volixibat in patients with PBC showed 3.
8 point reduction from baseline and -2.32 points placebo-adjusted (p=0.0026) reduction in primary endpoint of pruritus.
In addition, 75% of patients on volixibat achieved a greater than 50% reduction in serum bile acids. No new safety signals were observed, and adverse events were similar between the 20 mg and 80 mg treatment groups. Based on these results, the VANTAGE PBC trial will continue with a volixibat dose of 20mg twice daily.
The company also added that the VISTAS PSC interim analysis exceeded the efficacy threshold for study continuation. The independent data review committee recommended that the study continue with the selected volixibat dose of 20mg twice daily, with no changes to the study. Press release.
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