Shots:
- Mirum has reported global P-IIb (VISTAS) trial data evaluating volixibat (20mg, BID) vs PBO in 158 patients with cholestatic pruritus caused by PSC, incl. 111 pts in the primary analysis cohort with mod. to sev. itch & 47 pts in the secondary cohort with mild itch
- In the primary cohort, volixibat met the 1EP, showing a 2.72-point improvement in pruritus vs -1.08 on the Adult ItchRO scale, with significant itch reduction observed within 2wks. & sustained over 12wks.; 55.6% pts achieved a ≥2-point itch reduction vs 26.3%. Data to be presented at EASL’26
- Mirum has scheduled a pre-NDA meeting with the US FDA for volixibat in PSC in summer 2026, with NDA submission planned for H2’26, while topline data from the Phase IIb (VANTAGE) study in Primary Biliary Cholangitis are now expected in Q1’27
Ref: Businesswire | Image: Mirium | Press Release
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