• DURECT Corporation's larsucosterol demonstrates potential in treating alcohol-associated hepatitis (AH) by reducing mortality rates in U.S. patients.
• A Phase 3 trial, agreed upon with the FDA, will assess larsucosterol's efficacy with a 90-day survival primary endpoint, aiming for topline data within two years.
• Larsucosterol targets DNA methyltransferases, epigenetic enzymes linked to hypermethylation in AH, offering a novel approach to managing the condition.
• Data from the AHFIRM Phase 2b trial supports the Phase 3 design, showing significant mortality reduction with larsucosterol in U.S. patients.