Vital Therapies Inc, a biotherapeutic company developing ELAD, a cell-based therapy targeting the treatment of liver failure, announced that it has received written responses from the US FDA to its Type C meeting request on the planned VTL-308 phase 3 clinical trial.
At the FDA's suggestion, the Company has incorporated an event-driven feature into the trial design consistent with the primary endpoint of overall survival. Under the modified design, enrollment will continue until at least 150 subjects have been enrolled and 55 events have occurred, consistent with the event rate seen in the target subpopulation from VTI-208.
In light of the FDA's guidance on trial design and other topics, the VTL-308 program remains on track. Clinical sites are in the process of opening, with enrollment of the first subject expected in the first half of 2016, and final data anticipated in mid-2018.
VTL-308 is a planned phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with alcohol induced liver disease (AILD) who meet criteria based on learnings from pre-specified and post-hoc analyses of the recently completed VTI-208 clinical trial. Subjects must be under the age of 50, have a MELD score under 30, an INR of 2.5 or below, a creatinine level below 1.3 mg/dL, and a bilirubin level of at least 16 mg/dL. The primary endpoint is overall survival through at least 91 days assessed using the Kaplan Meier statistical method. The trial is intended to enroll a minimum of 150 subjects, who will be randomized 1:1 to either ELAD therapy plus standard-of-care, or standard-of-care alone. The Company expects to enroll subjects among roughly 40 sites in the United States, the United Kingdom, Ireland, Germany and Spain, with first patient enrollment projected to occur in the first half of 2016, and final data expected around mid-2018.
