Vital Therapies Plans Phase 3 Trial Of ELAD In Liver Decompensation, Hepatitis

(RTTNews) - Vital Therapies, Inc. (VTL) Monday revealed its plans for a possible new phase 3 clinical trial designed to confirm ELAD's safety and efficacy in alcohol-induced liver decompensation and severe acute alcoholic hepatitis.

The phase 3 trial will be based on identified medically pertinent pre-specified trends in its recently concluded VTI-208 clinical trial, though it has not reached its primary and secondary endpoints. Since then, the company has conducted a series of pre-specified and post-hoc analyses of subsets of the data to determine if there is a basis for designing and implementing a new clinical trial to confirm the efficacy and safety signals identified in these subsets.

The Company has drafted a preliminary protocol VTL-308, incorporating limits on age and factors associated with kidney dysfunction and blood clotting dysfunction, which are discrete components of the Model for End Stage Liver Disease score.

Around 150 subjects would be enrolled for VTL-308, starting from the first half of 2016. Clinical sites will be begun in fourth quarter, with approximately 35 sites in U.S., U.K., Ireland, Germany and Spain.