Durect announces last patient’s last visit in Phase 2b AHFIRM trial

DURECT Corporation announced that the last patient has completed the study protocol in the Company’s AHFIRM trial. AHFIRM is a Phase 2b randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of lasucosterol in subjects with severe alcohol-associated hepatitis. A total of 301 patients were randomized and dosed in AHFIRM and DURECT plans to report topline data in the fourth quarter of 2023. “We are pleased to have completed follow-up of all patients in our Phase 2b AHFIRM trial, bringing us one step closer to reporting topline data from the study which we anticipate in the fourth quarter of 2023,” stated James E. Brown, D.V.M., President and CEO of DURECT. “Assuming a positive outcome from AHFIRM, we plan to review the results with the U.S. Food and Drug Administration (FDA) in the first quarter of 2024. We designed AHFIRM to be a potentially pivotal trial and hope to expedite regulatory discussions through the Fast Track Designation that the FDA previously granted. If approved, larsucosterol would be the first FDA-approved treatment for alcohol-associated hepatitis (AH) and would represent a paradigm shift in the management of this life-threatening disease.”