US-based biopharma DURECT has unveiled data from its Phase IIb AHFIRM trial of larsucosterol for the treatment of alcohol-associated hepatitis.
Larsucosterol is an epigenetic modulator that inhibits DNA methylation, leading to the modulation of gene expression related to stress responses, cell survival, inflammation, and lipid biosynthesis.
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Data showed that there was an improvement in the primary endpoint of reducing mortality or the need for a transplant in 90 days, but it didn’t reach statistical significance for 30mg and 90mg doses of larsucosterol.
The AHFIRM trial, which enrolled 307 patients, is a randomised, double-blind, placebo-controlled, international, multi-centre study that enrolled patients from more than 60 sites across Australia, the UK, the EU, and the US and divided into three arms with 100 in each group.
Patients in the first arm received a placebo and supportive care with or without methylprednisolone capsules (steroids). Subjects in the second and third arms received 30mg and 90mg of larsucosterol respectively, without steroids. Those in the larsucosterol arms were also administered with matching placebo capsules if the investigator prescribed steroids.
Both doses of larsucosterol showed a significant trend in reducing mortality at 90 days. The 30mg dose reduced mortality by 35% and the 90mg dose reduced it by 41% compared to standard treatment (SOC).
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By GlobalDataDurect plans to meet with the US Food and Drug Administration (FDA) to discuss these results and the design of a Phase III registration trial in early 2024.
Durect president and CEO James Brown said: “We have a strong rationale to advance larsucosterol into a Phase III registration trial designed with adequate power to detect a statistically significant result using 90-day mortality as the primary endpoint. We look forward to meeting with the FDA to discuss the next steps.”
Shares in the Nasdaq-listed company plummeted by nearly 65% in premarket trading Wednesday following the announcement.
The FDA granted larsucosterol fast track designation in December 2020.
According to GlobalData, larsucosterol is forecast to generate $530m in sales in 2029.
GlobalData is the parent company of Clinical Trials Arena.
