Vital discontinues ELAD system after Phase III miss

Vital Therapies Inc. (NASDAQ:VTL) said it will discontinue development of its ELAD system and explore strategic options. The move comes after newly released data showed that the ELAD system missed the primary and secondary endpoints in the open-label, international Phase III VTL-308 trial to treat alcohol-induced liver decompensation. ELAD is a human liver cell-based extracorporeal liver assist device.

In VTL-308, ELAD plus standard of care (SOC) showed no significant differences on the primary endpoint of overall survival (OS) through at least day 91 or the secondary endpoint of the proportion of survivors at day 91 vs. SOC alone. Based on the data, Vital said it does not believe the ELAD system can be approved in the U.S. or EU without additional clinical trials...