Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 3 EXPAND Study of LIVMARLI® (maralixibat) in Ultra-Rare Cholestatic Liver Diseases
Mirum Pharmaceuticals announced that the Phase 3 EXPAND study of LIVMARLI (maralixibat) met its primary endpoint, showing a statistically significant reduction in cholestatic pruritus versus placebo (p=0.0004) in patients with ultra-rare cholestatic liver diseases. Maralixibat also produced a 69% reduction in serum bile acids versus placebo, and results were significant across all five prespecified secondary endpoints, including in the biliary atresia with native liver subgroup. The 52-patient study showed no new safety signals. Mirum plans a U.S.
Key figures
- Drug Name
- LIVMARLI (maralixibat)
- Phase Of Trial
- Phase 3
- Patients enrolled
- 52
- Sba treatment effect
- 69.0% reduction vs placebo (p<0.0001)
- Secondary endpoints met
- 5
- Primary endpoint p value
- 0.0004
- Biliary atresia itch p value
- 0.0002
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.