In a significant development for DURECT Corp, the late-stage biopharmaceutical company witnessed a sharp decline in its stock value following the release of topline results from its AHFIRM trial. This Phase 2b study, characterized by its randomized, double-blind, placebo-controlled design, aimed to assess the safety and efficacy of larsucosterol in 307 patients afflicted with severe alcohol-associated hepatitis (AH).
At the time of this publication, DURECT Corp stock (DRXX) has witnessed a decline.
DURECT Corp
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Key findings from the AHFIRM trial indicated that both the 30 mg and 90 mg larsucosterol doses exhibited a notable and clinically substantial trend in reducing mortality at the critical 90-day mark, a secondary endpoint of paramount importance. The 30 mg arm demonstrated a mortality reduction of 41% (p=0.070), while the 90 mg arm exhibited a reduction of 35% (p=0.126) compared to the Standard of Care (SOC).
However, it is worth noting that the numerical improvement in the primary endpoint, which assessed mortality or the necessity for a transplant at 90 days, did not reach statistical significance for either dosage of larsucosterol.
A notable observation emerged with both doses of larsucosterol demonstrating a more pronounced decrease in mortality rates among U.S.-based participants, constituting 76% of the trial’s enrollees. In this subgroup, the 30 mg arm witnessed a mortality reduction of 57% (p=0.014), while the 90 mg arm saw a reduction of 58% (p=0.008) compared to SOC.
Furthermore, the trial affirmed the safety and well-tolerated nature of larsucosterol, as evidenced by the lower incidence of treatment-emergent adverse events (TEAEs) in the larsucosterol arms in comparison to SOC.
Looking ahead, DURECT is set to convene an End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) during the first quarter of 2024. This meeting will serve as a platform to deliberate on the trial’s results and the design for the Phase 3 registration trial. Additionally, DURECT intends to share the AHFIRM trial results at an upcoming medical conference, further disseminating the noteworthy outcomes of the study.
