Vital Therapies’ (NASDAQ:VTL) VTL-308 Phase 3 trial to evaluate its cell-based therapy, ELAD, in subjects with severe alcoholic hepatitis has reached its enrollment target of 150 subjects.
Subjects in VTL-308 were randomized 1:1 to either ELAD plus standard-of-care, or standard-of-care alone. The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method.
During the first quarter of 2018, a review by independent statisticians concluded that the overall event rate experienced in VTL-308 subjects through yearend 2017 was consistent with the trial’s original statistical plan, and recommended the company retain the trial’s original enrollment target of 150.
Vital remains on track to report top line results for VTL-308 in the third quarter, likely in September.
