DURECT has begun patient dosing in a Phase lla clinical trial of DUR-928 for treating patients with alcoholic hepatitis (AH).
The open-label dose escalation study will be conducted in two parts. In Part A, patients with moderate AH as determined by the model for end-stage liver disease (MELD) scores will be enrolled, while Part B will include patients with severe AH.
Part A of the trial will use three dose levels of DUR-928, including 30mg, 90mg and 150mg. The trial will also be conducted using sequential dose escalation following review of safety and pharmacokinetics (PK) results of the prior dose level.
Patients will be given DUR-928 by intravenous infusion, and the dose may be changed in Part B based on the findings from Part A.
For the trial, 24-36 patients are expected to be enrolled across five clinical sites in the US, including Piedmont Atlanta Hospital, Georgia.
The trial’s objectives are safety and PK. It will also observe pharmacodynamic (PD) signals that include liver biochemistry, MELD and Lille scores, as well as other biomarkers.
Data from the trial is expected to be available within the year.
Piedmont Atlanta Hospital representative Dr Lance Stein said: “There is a clear unmet medical need to find effective medical therapy in acute alcoholic hepatitis, so we look forward to seeing how these patients respond when treated with this intravenously administered endogenous small molecule.”
DURECT’s investigational product DUR-928 is an endogenous, small molecule, which could be used to treat several diseases such as non-alcoholic steatohepatitis.
It can also be used to treat other disorders of the liver such as primary sclerosing cholangitis (PSC), in acute organ injuries.