Durect announces completion of enrollment in its phase 2a clinical trial of dur-928 in psoriasis and 50% enrollment in its phase 1b dur-928 clinical trial in nash
Durect corporation announced that it has completed enrollment in its phase 2a clinical trial of topical dur-928 in patients with mild to moderate plaque psoriasis. the company also announced that it has now enrolled 30 of the planned 60 patients in its ongoing phase 1b trial with oral dur-928 in patients with non-alcoholic steatohepatitis (nash). the company expects to announce top line data from the psoriasis trial by the end of this year. the nash trial is on schedule to be completed in the first half of 2020 and the company plans to announce top line study results following completion of the trial. the trial is a phase 2a, randomized, double-blind, vehicle-controlled, multi-center, proof-of-concept study in which dur-928 is applied topically once-daily for 28 days with a 28-day follow-up period in patients with mild to moderate plaque psoriasis. the trial is being conducted in the u.s. the plan was to enroll at least 20 patients to have 15 evaluable patients. at the time of this announcement, more than 20 patients have been enrolled. each patient serves as their own control, applying dur-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. after the treatment period, patients will be followed for an additional four weeks. the primary efficacy endpoint is change in local psoriasis scores from baseline in the dur-928-treated plaques compared to the vehicle-treated plaques. in march 2019 the company began enrolling patients in a phase 1b randomized and open-label clinical study being conducted at multiple centers in the u.s. to evaluate safety, pharmacokinetics (pk) and signals of biological activity of dur-928 in nash patients with stage 1-3 fibrosis. patients take oral dur-928, at one of three doses (50 mg qd, 150 mg qd and 300 mg bid), daily for 28 consecutive days and are then followed for 28 days. the plan is to enroll 20 patients per dose group (with 15 evaluable) for a total of approximately 60 patients in the trial. key endpoints include safety, pk, and signals of biological activities, including clinical chemistry and biomarkers as well as liver fat content by imaging.
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