other material
confidence high
sentiment positive
materiality 0.70
Mirum reports positive interim Ph2b data for volixibat in PBC and PSC
Mirum Pharmaceuticals, Inc.
- VANTAGE PBC trial: volixibat achieved placebo-adjusted -2.32 point itch reduction (p=0.0026); 75% of patients had >50% drop in serum bile acids.
- Significant fatigue improvement at week 16; no new safety signals; diarrhea (77%) mostly mild/moderate and transient; 4 SAEs (1 placebo).
- VANTAGE and VISTAS PSC trials to continue with volixibat 20 mg twice daily; independent data review committee recommended continuation for PSC.
- No clinically meaningful changes in liver biomarkers in PBC; sponsor remains blinded to interim results.