Durect Corporation announced preliminary data from an ongoing phase 2a trial of DUR-928 for alcohol-related hepatitis, according to a press release.
To date, 10 patients with moderate to severe alcohol-related hepatitis have completed dosing with DUR-928, eight of whom received 30 mg dose while the other two received 90 mg dose.
Among the nine patients who returned for their day 7 visit, the Lille score was 0.04 compared with a cohort of 15 patients treated with either supportive care or supportive care with corticosteroids (0.41). According to the researchers, seven patients’ Lille scores met criteria for complete response and the other two patients met criteria for partial response.
Total bilirubin reduction went from 16% at day 7 and 41% at day 28 in patients who received DUR-928 compared with 3% at day 7 and 35% at day 28 in the supportive care cohort. MELD score reduction from baseline was 4% at day 7 and 21% at day 28 in treated patients compared with 4% increase at day 7 and 6% reduction at day 28 in the supportive care cohort.
The researchers have observed no statistical difference in the pharmacokinetic profiles between patients with moderate and severe alcohol-related hepatitis who received DUR-928 and no drug-related adverse events.