DURECT Corp. (DRRX:NASDAQ) announced in a news release preliminary data from the ongoing DUR-928 dose escalation, Phase 2a clinical trial in patients with alcoholic hepatitis.
Results were provided for 10 study patients, eight of whom were treated with intravenous DUR-928 30 milligrams (30 mg) and two with DUR-928 90 mg. Half of the total patients had moderate disease, the remainder, severe.
Patients were evaluated using two scoring systems: Lille and MELD, or the model of end-stage liver disease. Both are used to determine disease severity and prognosis in alcoholic hepatitis patients. The lower the score for each metric, the better the prognosis for the patient.
Regarding the Lille, the median score was 0.04 for the nine patients who received DUR-928 and returned for their Day 7 visit. (One patient did not show.) Their scores ranged from 0.01–0.19, indicating an 85% chance of surviving for six months. Their Lille outcomes were significantly lower than the 0.41 median Lille score of the historical control group of 15 patients who received supportive care with or without corticosteroids.
With respect to MELD, nine of the 10 DUR-928-dosed patients demonstrated a 4% median reduction in their score on Day 7 from baseline, or pretreatment. Eight patients showed a 21% median drop at Day 28. These scores compare to a 4% increase and a 6% median MELD score reduction, respectively, in the same historical control group.
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