DURECT has started dosing patients in a Phase IIa clinical trial of DUR-928 to treat patients with primary sclerosing cholangitis (PSC).
The trial is a randomised, open-label study with two cohorts including a low dose cohort of 10mg and a high dose cohort of 50mg. Each cohort will include 20 patients.
As part of the study, patients in each cohort will receive oral dosing of DUR-928 for four weeks with follow-up for an additional four weeks.
The study’s endpoints include safety, pharmacokinetic (PK) and pharmacodynamic (PD) markers such as the percent change from baseline of serum alkaline phosphatase (ALP) and other biomarkers.
Data from the study are expected to be generated during the course of the year and are set to help future PSC trials and for other liver conditions including nonalcoholic fatty liver disease (NASH).
California Pacific Medical Centre autoimmune liver disease programme medical director Dr Kidist Yimam said: “There is a clear unmet medical need to find effective medical therapy in PSC and prevent progression to end-stage liver disease, so we look forward to seeing how these patients respond when treated with this orally administered endogenous small molecule.”
The centre is among the 15 sites planned for the study and the first site to enrol a patient.
Durect’s DUR-928 is the lead investigational product of the company’s epigenetic regulator programme.
It is an endogenous, small molecule, which has the potential to be used in several hepatic and renal diseases such as NASH, in acute organ injuries such as acute liver and kidney injury, and in inflammatory skin disorders including psoriasis and atopic dermatitis.