DURECT (DRRX) Oppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025 summary

Disease background and unmet need

• Alcohol-associated hepatitis causes 160,000 hospitalizations and 30,000-40,000 deaths annually in the U.S., with a 30% 90-day mortality rate.

• The disease costs the U.S. healthcare system over $10 billion yearly and accounts for about a quarter of liver transplants.

• Standard of care is mainly supportive, with corticosteroids used in 40% of cases but shown to be ineffective in improving long-term survival.

Drug development and clinical results

• Larsucosterol, licensed from Virginia Commonwealth University, has shown efficacy in multiple nonclinical models and in NASH patients.

• Phase II-B trial showed 30%-40% global mortality reduction and 57%-58% reduction in U.S. patients, with fewer adverse events.

• The trial's global design led to variability; U.S. patients were younger and dosed sooner, showing better outcomes.

• FDA granted breakthrough designation; a single successful U.S. trial could enable approval.

Phase III trial design and operational changes

• Phase III will focus on U.S. sites, randomize by site, and require dosing within nine days to reduce variability.

• Primary endpoint will be 90-day survival, not a composite with liver transplant.

• Estimated trial cost is $20 million, with a two-year timeline from initiation to data readout.