Vital Therapies, Inc. is a clinical-stage biotechnology company focusing on the discovery, development and commercialization of cell-based therapies capable of transforming the management of life-threatening conditions. Our initial product candidate, the ELAD® System, or ELAD, is a human-cell-based, bio-artificial liver which is being developed to improve rates of survival among patients with acute forms of liver failure.
We believe that the ELAD System may improve rates of overall survival and transform the management of acute forms of liver failure. Therapy with ELAD consists of a single, up to five-day treatment session, during which a patient’s blood plasma is passed continuously through four cartridges containing approximately one pound of VTL C3A cells. These cells, which are grown by us from our proprietary cell banks, are human, liver-derived cells, which have been shown to retain a large number of the liver’s synthetic and metabolic functions. During therapy with the ELAD System, we believe that the VTL C3A cells may infuse the patient’s plasma with beneficial proteins, including growth factors, cell survival proteins, and anti-inflammatory proteins, and also remove certain harmful substances, such as endotoxin, all of which may better allow the patient’s own liver to recover and regenerate, thereby potentially improving patient survival. The ELAD System has been granted orphan drug designation by the U.S. Food and Drug Administration, or FDA, and the European Commission, for the treatment of patients with acute liver failure, including alcoholic hepatitis.
As part of ELAD’s clinical development program, over 250 subjects have received treatment with the ELAD System through prior clinical trials and a compassionate use program. Although VTI-208, our Phase 3 clinical trial evaluating ELAD in sAH, failed to reach either the primary or secondary endpoints, data from pre-specified and post-hoc analyses of this study has shown trends that may indicate a potential to increase survival rates in certain subsets of subjects with liver failure due to acute hepatocellular insult and alcohol use.
Based on our analysis of VTI-208 subsets, we are pursuing a new phase 3 clinical trial in sAH, referred to as VTL-308. VTL-308 is a phase 3 randomized, controlled, open-label trial, designed to evaluate the ELAD System in subjects with severe alcoholic hepatitis who meet criteria based on learnings from pre-specified and post-hoc analyses of the VTI-208 clinical trial. The Company enrolled the first subject in VTL-308 in May 2016 and expects data in third quarter 2018.