Immunic Therapeutics

Vital Therapies is a biotherapeutic company focused on developing a cell-based therapy targeting the treatment of acute liver failure. Their product candidate, the ELAD System, or ELAD, is a bio-artificial liver therapy that operates outside the body, or extracorporeal, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. ELAD is an allogeneic cellular therapy system incorporating their human liver-derived C3A cells contained in four hollow fiber cartridges that are combined with a single-use customized disposable set and a reusable bedside unit. Data from ELAD clinical studies have shown trends that may indicate the potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of their ongoing Phase III clinical trial program, more than 150 subjects have received ELAD therapy in seven clinical trials and through a compassionate use program, which they believe collectively suggests a promising therapeutic profile. They are currently initiating three Phase III clinical trials in various acute liver failure conditions. In March 2013, they initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. In the fourth quarter of 2013, they intend to initiate two additional Phase III randomized controlled trials, VTI-210, in 120 subjects with acute alcoholic hepatitis, and VTI-212, in 126 subjects with fulminant hepatic failure.