DURECT has concluded the enrolment of patients in the Phase IIb clinical trial of larsucosterol for the treatment of severe alcohol-associated hepatitis (AH).
With this, the company has achieved its enrolment target of 300 subjects.
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The multi-centre, placebo-controlled, international, double-blind, randomised study enrolled patients with AH to evaluate the safety and efficacy of laRsucosterol treatMent (AHFIRM).
Patients were enrolled from more than 60 sites across Australia, the UK, the EU, and the US and divided into three arms with 100 in each group.
At the investigators ‘ discretion, 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.
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By GlobalDataThose in the larsucosterol arms were also administered with matching placebo capsules if the investigator prescribed steroids.
Liver transplantation or 90-day incidence of death in patients treated with larsucosterol against placebo is the primary outcome measure.
DURECT president and CEO James Brown said: “We are excited to have reached this critical milestone and look forward to reporting topline data, anticipated in the fourth quarter of 2023.
“We are preparing to file a new drug application for larsucosterol in AH pending a positive AHFIRM trial outcome and Food and Drug Administration (FDA) guidance and hope to expedite regulatory discussions through the Fast Track Designation that DURECT was previously granted by the FDA.
“In parallel, we are working on the early stages of commercial launch planning in the US.”
