2023-11-08 06:50:22 ET
Durect Corporation ( NASDAQ: DRRX ) lost ~63% in the pre-market Wednesday after a mid-stage study for its lead candidate, larsucosterol, didn’t reach the primary endpoint with statistical significance in patients with alcohol-associated hepatitis (AH).
Citing topline data from its Phase 2b AHFIRM trial, Cupertino, California-based Durect ( DRRX ) said that both 30 mg and 90 mg doses of larsucosterol caused “a compelling and clinically meaningful trend in reduction of mortality” over 90 days.
However, the effects on the 90-day incidence of mortality or liver transplantation, AHFIRM’s primary goal, were not statistically significant for either dose compared with the standard of care (SOC).
The placebo-controlled study enrolled 307 subjects with severe alcohol-associated hepatitis across three groups of approximately 100 patients in multiple trial sites in the U.S., EU, U.K., and Australia.
As for safety, Durect ( DRRX ) said that the experimental therapy was well tolerated, with fewer treatment-emergent adverse events seen in patients who received larsucosterol compared to those on SOC.
The company intends to discuss the data with the FDA in Q1 2024 to design a Phase 3 registrational trial for the candidate.
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- Financial information for DURECT
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Durect plummets as lead asset fails in mid-stage trial for liver disorder