Durect corporation announces the results of its phase 2a clinical trial of dur-928

On november 12, 2019, durect corporation announced the results of its phase 2a clinical trial of dur-928 (the “trial”) in alcoholic hepatitis (ah), presented as a late-breaking oral presentation at the liver meeting®. additionally, the trial results were selected for inclusion in the ‘best of the liver meeting’ summary slide presentation in the alcohol-related liver disease category. all patients treated with dur-928 in the trial survived the 28-day follow-up period and there were no drug-related serious adverse events. patients treated with dur-928 had a statistically significant reduction from baseline in bilirubin at day 7 and 28, and meld at day 28. lille scores were also statistically significantly lower than those from a well-matched group of patients in a contemporary ongoing trial as well as several published historical controls. 74% of all dur-928 treated patients and 67% of those with severe ah were discharged from the hospital within four days of receiving a single dose of dur-928. lille scores are used in clinical practice to help determine the prognosis and response of ah patients after seven days of treatment. the lower the lille score, the better the prognosis. patients with a lille score below 0.45 have a six-month survival rate of 85% compared to those with lille scores above 0.45, with only a 25% six-month survival rate.1 the chart below shows the lille scores for individual ah patients treated with dur-928 plotted as a function of their baseline meld scores. in the trial, the median lille score for patients treated with dur-928 was 0.10. the median lille score among a cohort of 15 patients treated with standard of care at the university of louisville (ul) was 0.41 (shown as historical control). 100% of patients in the 30mg and 90mg dur-928 dosing groups were treatment responders based on their lille scores. 89% of the overall dur-928 patient population were treatment responders. patients with severe ah, as defined by maddrey’s discriminant function >32 or meld 21-30, and baseline serum bilirubin above 8 mg/dl, had similarly high response rates to dur-928 treatment. the lille scores of patients treated with dur-928 in the trial were also significantly lower than several selected published historical studies (hepatology 2007, 45:1348-1354; gut 2011, 60:255-260), in which patients had similar baseline bilirubin, albumin, creatinine, prothrombin time and df scores, and were treated with standard of care with or without corticosteroids. notwithstanding the foregoing, such comparisons should be taken cautiously due to the historical nature of the studies. a sub-group analysis was conducted to compare severe ah patients in the 30mg and 90mg dosing groups (n=8) with well-matched severe ah patients (n=13) who received corticosteroids for 28 days in a contemporaneous study at the university of louisville (ul). patients shown below in the ul steroid group had a mean baseline meld of 24.46 and mean baseline maddrey’s df score of 62.98. the eight patients in the dur-928 group had baseline mean meld of 24.50 and mean baseline maddrey’s df score of 61.25. all patients treated with dur-928 survived the 28-day follow up period, while three patients in the ul steroid group died within the first 28 days.
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