HomeMarket NewsMicro Cap StocksUnderstanding the Plunge in DURECT Stock Amid AHFIRM Phase 2b Study Results

Understanding the Plunge in DURECT Stock Amid AHFIRM Phase 2b Study Results

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DURECT Corporation
DRRX recently announced the topline results from its AHFIRM Phase 2b study of larsucosterol involving 307 patients with severe alcohol-associated hepatitis (AH).

The primary endpoint of mortality or transplant at 90 days did not show statistical significance for either dose of larsucosterol.

However, both the 30 mg and 90 mg larsucosterol doses demonstrated a clinically meaningful trend in reducing mortality at 90 days, a key secondary endpoint. This reduction stood at 41% (p=0.070) in the 30 mg arm and 35% (p=0.126) in the 90 mg arm compared with Standard care (SOC).

  • Notably, both doses of larsucosterol exhibited a higher reduction in mortality among patients enrolled in the U.S., constituting 76% of the trial participants. In this subset, 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 in comparison to SOC.
  • Furthermore, larsucosterol proved to be safe and well tolerated, with fewer treatment-emergent adverse events (TEAEs) in the larsucosterol arms when compared to SOC.

Looking ahead, DURECT plans to hold an End of Phase 2 meeting with the FDA in Q1 2024 to deliberate on the trial results and the design of the Phase 3 registration trial.

Price Action: DRRX shares witnessed a decline of 75.90%, settling at $0.62 in the recent update on Wednesday.

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