DURECT Corporation Announces Phase 3 Registrational Trial Design for Larsucosterol in Alcohol-associated Hepatitis
DRRXDURECT (DRRX) Prnewswire·2024-09-25 20:00
  • Type B meeting with FDA held under Breakthrough Therapy designation resulted in agreement on key aspects of Phase 3 trial design- Single Phase 3 trial designed to enroll 200 U.S. patients with a 90-day survival primary endpoint; topline results expected within two years of trial initiation - Protocol for Phase 3 trial builds on data from the AHFIRM Phase 2b trial; 30 mg and 90 mg doses of larsucosterol reduced 90-day mortality in U.S. patients by 57% and 58%, respectively, compared with placeboCUPERTINO, ...