Vital Therapies, Inc. is a biotherapeutic company developing ELAD®, an extracorporeal human hepatic cell-based liver treatment. ELAD is designed to improve survival in patients with liver failure by providing hepatic support continuously for up to five days. We believe that use of ELAD allows time for the patient’s native liver to recover from an acute decompensation, stabilize, and then potentially regenerate, or to maintain the patient until liver transplantation can occur.
The ELAD System incorporates approximately 440 grams of our human liver-derived cells, or VTL C3A cells, contained in four hollow-fiber cartridges, that are combined with disposable components and a reusable delivery device. During treatment with ELAD, blood is drawn from the patient via a central venous line and then passes into the delivery device where plasma ultrafiltrate is isolated. The patient’s plasma ultrafiltrate then passes through hollow fibers contained within the four cartridges, where semipermeable fibers permit bidirectional flow between the VTL C3A cells and the ultrafiltrate. In vitro research suggests that VTL C3A cells add proteins to the ultrafiltrate, and may remove substances typically metabolized by the liver. Treatment is expected to consist of a single, continuous session lasting between three and five days, as determined by the treating physician.
The ELAD System is the only liver support system containing human liver-derived cells to enter Phase 3 clinical trials. We designed the ELAD System to supplement key aspects of normal liver function to improve patient survival. Outside of liver transplant, which is severely limited by the availability of organs and not available to many patients, the current standard of care for the treatment of liver failure is primarily focused on the management of complications, which does not restore lost liver function and is associated with a high rate of mortality.
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 alcohol-induced liver decompensation (AILD), 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 AILD, 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 acute 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.
ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure.