Mirum reports positive Phase 2b PSC itch data for volixibat

Mirum Pharmaceuticals said its Phase 2b VISTAS trial of volixibat met the primary endpoint in adults with primary sclerosing cholangitis, or PSC, who have cholestatic pruritus. In the primary analysis cohort, volixibat produced a 2.72-point reduction from baseline on the Adult ItchRO scale versus 1.08 points with placebo, for a placebo-adjusted difference of 1.64 points, with statistically significant improvement seen within two weeks. Mirum said the safety profile was generally consistent with IBAT inhibition, with gastrointestinal adverse events and liver lab elevations among the main findings, and it has scheduled a pre-NDA meeting with the FDA for summer 2026 ahead of a planned U.S. submission in the second half of 2026. Full data are slated for a late-breaking oral presentation at the EASL Congress on May 30, 2026. (biospace.com)

Why it matters: For veterinary professionals tracking translational liver and pruritus therapeutics, the result adds to growing momentum around ileal bile acid transporter, or IBAT, inhibition as a targeted way to reduce itch burden in cholestatic disease. PSC still has no approved medical therapy, and cholestatic pruritus remains a major quality-of-life issue with limited treatment options, so a positive controlled study in this setting is notable even beyond human hepatology. (journals.lww.com)

What to watch: Watch for the full EASL dataset on May 30, 2026, and for details from Mirum’s FDA meeting and planned NDA filing later this year. (nasdaq.com)