Vital Therapies was evaluating the ELAD® System for the treatment of patients with acute forms of liver failure in a clinical development program. Currently, ELAD is in Phase 3 development for the treatment of severe alcoholic hepatitis (sAH) in its VTL-308 clinical trial.
Other potential indications for ELAD may include:
- A treatment for acute flares of viral hepatitis B
- A bridge-to-transplant for patients with acute forms of liver failure waiting for a liver transplant
- A treatment for patients with small-for-size or split liver transplant; ELAD may be able to support the patient’s liver function until the donated organ regenerates to a size large enough to become independent of external support, or it could enable transplantation of smaller liver fragments than typically used
- A treatment for post-surgical liver failure including in patients with primary liver cancer who undergo resection of the cancerous part of the liver; ELAD may be able to support these patients while their liver regenerates and enable surgeons to perform larger tumor resections
To date, more than 300 patients globally have received treatment with ELAD in clinical trials and in a compassionate use program, and 51 academic centers and large urban hospitals have participated in the VTI-208 or VTL-308 clinical trials.
The ELAD System has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of acute forms of liver failure.