Mirum's Livmarli Meets Primary Endpoint in Phase 3 Trial for Cholestatic Pruritus
Mirum Pharmaceuticals (MIRM) announced that its phase 3 trial of Livmarli (maralixibat) met the primary endpoint for treating cholestatic pruritus, a severe itching condition linked to impaired bile flow in patients aged six months and older with rare liver diseases. The EXPAND trial evaluated the drug's efficacy across various cholestatic liver disorders such as Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). Meeting its primary endpoint is a significant milestone for Mirum, potentially paving the way for regulatory approval. The success of this phase 3 study could enhance Livmarli’s market potential in treating rare pediatric liver diseases. The drug was previously approved by the FDA and EMA for Alagille syndrome-related pruritus in children under six years old. Positive trial results may attract investor interest, especially as there are limited treatment options available for these conditions. This development could also support Mirum’s broader strategy to expand Livmarli's indications across different cholestatic diseases.
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