Vital Therapies is abandoning its cell-based therapy for liver failure and “considering strategic options” after it did not improve overall survival—the primary endpoint—in a late-stage study. The company’s stock dropped more than 88% in premarket trading.
The ELAD system is a liver cell-based therapy designed to “promote the recovery and regeneration” of a patient’s failing liver. The VTL-308 study, which finished enrolling in March, was a randomized, controlled, open-label trial testing ELAD in patients with severe alcoholic hepatitis. The primary endpoint was overall survival through a minimum of 91 days, a goal the study did not meet. There was also no statistically significant difference in the number of surviving patients at day 91 between the treated group and the control group.
“In light of these results, the Company does not believe the ELAD System can be approved in the United States or European Union, if ever, without additional clinical trials that would require substantial capital and time to complete,” Vital Therapies said in a statement. “Consequently, the Company will cease any further development of the ELAD System and explore strategic options.”
The San Diego-based company did not elaborate on what these options might be, but it is a one-trick pony that has previously said the ELAD system might be applied to other forms of liver disease, such as hepatitis B, or used as a bridge-to-transplant.
Vital Therapies filed to raise up to $86 million in its IPO before aborting the attempt in November 2013. It finally went public in 2014 in a downsized $54 million offering. About a year later, it suffered a phase 3 failure in patients with alcohol-induced liver decompensation, missing the same primary endpoint as the VTL-308 trial did and sending its stock down 80%.