Durect announces additional data from larsucosterol trial

Durect announced that additional data from the company’s previously completed Phase 2a trial evaluating larsucosterol in alcohol-associated hepatitis, or AH, has been accepted by the peer-reviewed journal American Journal of Gastroenterology. In addition to previously reported safety and efficacy data from the 19-patient, open label Phase 2a trial, the publication includes cross-study comparisons of severe AH patients from the Phase 2a trial with two matching comparison arms from a contemporaneous study conducted by the DASH Consortium. The two well-matched comparison arms consist of an eight-patient observational arm and a separate 16-patient steroid-treated arm. Both comparison arms received standard-of-care including corticosteroids. 100% of patients treated with larsucosterol, including 12 patients with severe AH, survived the 28-day follow-up period compared to a historical 28-day mortality rate of 26%. Larsucosterol was well-tolerated and safe at the three doses studied when administered as one or two intravenous infusions in subjects with moderate or severe AH. The drug exposure was not affected by the disease severity and was dose proportional. 74% of patients treated with larsucosterol were discharged in under 4 days after a single dose. Rapid reductions from baseline of serum total bilirubin levels were observed at both Day 7 and Day 28 after larsucosterol dosing, including significant reductions from baseline in moderate AH patients at day 7 and in severe AH patients at day 28. Reductions of MELD scores from baseline were observed at Day 7 and Day 28. At Day 28, patients with moderate AH had statistically significantly lower MELD scores at Day 28 and those with severe AH had MELD scores that decreased from baseline at Day 28 but did not achieve statistical significance. All 8 severe AH patients in the 30 or 90 mg dose cohorts were treatment responders and their Lille scores were statistically lower than those of well-matched patients from the Observational Arm and Study-Steroid Arm of the DASH Consortium trial in a cross-study comparison. Both AST and ALT enzymes decreased rapidly in severe AH patients in the 30 or 90mg dose cohorts, with ALT being statistically significantly lower than those in the DASH patients in a cross-study comparison.