VISTAS Phase 2b trial met primary endpoint:
volixibat 20 mg BID reduced itch by 2.72 points on Adult ItchRO scale vs 1.08 for placebo (placebo-adjusted 1.64 points, p<0.0001) in 111 PSC patients with moderate-severe itch.
Statistically significant itch reductions observed within 2 weeks, also in mild itch cohort.
Pre-NDA FDA meeting scheduled for summer 2026, NDA submission planned for H2 2026.
Safety profile consistent with IBAT inhibitors:
higher GI events (diarrhea 40.3% vs 8.6% placebo) and discontinuations.
Total enrollment:
158 PSC patients; first potential treatment for cholestatic pruritus in PSC.
Announcement dated May 4, 2026.