Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- May 5
- 1 min read
04/05/2026
Mirum Pharmaceuticals’ Volixibat met its primary endpoint in a Phase 2b study in Patients with PSC (Ref)
Mirum Pharmaceuticals announced that the primary endpoint was met in the Phase 2b, VISTAS study, which evaluated volixibat (an IBAT inhibitor) in patients with primary sclerosong cholangitis (PSC).
Volixibat demonstrated a statistically significant and clinically meaningful 2.72-point reduction from baseline and a 1.64-point placebo-adjusted (p<0.0001) reduction in the primary endpoint of cholestatic pruritus.
Volixibat’s safety profile was generally consistent with the known effects of IBAT inhibition.
Mirum has scheduled a pre-New Drug Application (NDA) meeting with US FDA for volixibat in PSC for summer 2026, with an NDA submission planned for H2 2026.
The full results from the VISTAS study were to be presented in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) International Liver Congress on May 30.
