DURECT Corporation (Nasdaq: DRRX) today announced that it has completed the Phase 2a clinical trial of its lead product candidate, DUR-928, in patients with alcoholic hepatitis (AH). The final enrollment for the trial consists of 12 severe patients (MELD 21-30) and 7 moderate patients (MELD 11-20) for a total of 19 AH patients.
Clinical data from the trial show that the 19 patients treated with DUR-928 had statistically significantly greater reductions from baseline in bilirubin (day 7 and 28) and MELD (day 28), as well as statistically significantly lower Lille scores, compared with a historical control group (n=15) from a University of Louisville (UL) AH study.1
Lille scores are used in clinical practice to help determine the prognosis for AH patients after 7 days of treatment. The lower the Lille score, the better the prognosis is for the AH patient. Patients with a Lille score below 0.45 have an 85% 6-month survival rate vs. those with Lille scores of above 0.45, who have only a 25% 6-month survival rate (Louvet A et al. Hepatology 2007; 45: 1348-54). In our study, the median Lille score for the 18 AH patients treated with DUR-928 who returned for their Day 7 visit2 was 0.10. Eighty nine percent (16/18) had a Lille score below 0.45. The median Lille score among the UL cohort of 15 patients treated with either supportive care or supportive care with corticosteroids was 0.41, with 53% (8/15) having a Lille score below 0.45.
DUR-928 was well tolerated in all patients, with no drug-related serious adverse events reported at any dose level. Drug exposures were dose proportional and were uninfluenced by the severity of the disease.