Durect says AHFIRM study missed primary endpoint of mortality

Durect announced topline results from its AHFIRM trial, a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of larsucosterol in 307 patients with severe alcohol-associated hepatitis. Both the 30 mg and 90 mg larsucosterol doses demonstrated a “compelling and clinically meaningful” trend in reduction of mortality at 90 days, the key secondary endpoint, with mortality reductions of 41% in the 30 mg arm and 35% in the 90 mg arm compared with standard of care, the company said in a statement. The numerical improvement in the primary endpoint of mortality or transplant at 90 days did not achieve statistical significance for either dose of larsucosterol. Both doses of larsucosterol showed a more pronounced reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial, Durrect added. The reductions in mortality at 90 days were 57% for the 30 mg arm and 58% for the 90 mg arm compared with SOC. Larsucosterol was safe and well tolerated, according to the company. Durect intends to have an End of Phase 2 meeting with the Food and Drug Administration to discuss the trial results and the Phase 3 registration trial design in Q1 of 2024. “The topline results from AHFIRM provide compelling evidence that administration of larsucosterol can reduce mortality at 90 days in this devastating disease,” said James Brown, CEO of Durect.