DURECT Corporation DRRX released topline results from its AHFIRM Phase 2b study of larsucosterol in 307 patients with severe alcohol-associated hepatitis (AH).
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 the 30 mg and 90 mg larsucosterol doses demonstrated a clinically meaningful trend in reduction of mortality at 90 days, the key secondary endpoint, with mortality reductions of 41% (p=0.070) in the 30 mg arm and 35% (p=0.126) in the 90 mg arm compared with Standard care (SOC).
- Both doses of larsucosterol showed a higher reduction in mortality in patients enrolled in the U.S., representing 76% of patients enrolled in the trial. The reductions in mortality at 90 days were 57% (p=0.014) for the 30 mg arm and 58% (p=0.008) for the 90 mg arm compared with SOC.
- Larsucosterol was safe and well tolerated. There were fewer treatment-emergent adverse events (TEAEs) in the larsucosterol arms compared with SOC.
DURECT intends to have an End of Phase 2 meeting with the FDA to discuss the trial results and the Phase 3 registration trial design in Q1 2024.
Price Action: DRRX shares are down 75.90% at $0.62 on the last check Wednesday.
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