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DURECT Corporation Announces Publication of Larsucosterol Phase 2b Results in NEJM Evidence
DURECT DURECT (US:DRRX) Prnewswireยท2025-01-28 15:09

Core Insights - DURECT Corporation announced the publication of peer-reviewed data from the AHFIRM trial, focusing on the efficacy of larsucosterol for treating alcohol-associated hepatitis (AH) [1][2] - The AHFIRM trial was a Phase 2b study involving 307 patients, assessing the safety and efficacy of larsucosterol compared to placebo [2][4] - The company plans to initiate a Phase 3 trial in 2025, with the FDA indicating that a single successful trial could support a New Drug Application (NDA) [3][6] Trial Details - The AHFIRM trial was a randomized, double-blind, placebo-controlled study with three arms: placebo, larsucosterol 30 mg, and larsucosterol 90 mg [2][4] - The primary outcome measure was the 90-day incidence of mortality or liver transplantation [4][5] - The trial enrolled patients across 62 centers, with 76% of participants from the U.S. [2][4] Efficacy Results - Both larsucosterol doses showed trends in reducing 90-day mortality: 41% reduction (p=0.068) for 30 mg and 35% reduction (p=0.124) for 90 mg compared to placebo [5] - In U.S. patients, mortality reductions were more pronounced: 57% (p=0.014) for 30 mg and 58% (p=0.008) for 90 mg [5] - The overall mortality rates for AH patients are significant, with a third of severe AH patients not surviving beyond three months [3][7] Safety Profile - Larsucosterol was reported to be safe and well-tolerated, with treatment-emergent adverse events similar to those in the placebo group [5][6] - The study highlighted the importance of timely treatment for severe AH patients [5] Regulatory Status - The FDA has granted larsucosterol Fast Track and Breakthrough Therapy Designations for the treatment of AH, reflecting the urgent need for effective therapies in this area [6][9] - The company is focused on developing epigenetic therapies targeting dysregulated DNA methylation, with larsucosterol as its lead candidate [9]