Vital Therapies, Inc. is a biotherapeutic company that has been developing a cell-based therapy targeting the treatment of acute forms of liver failure. The Company’s ELAD® System, an extracorporeal human allogeneic cellular liver therapy, recently reported top-line data from its phase 3 clinical trial in severe alcoholic hepatitis. Although there was a numerical improvement in survival in the ELAD-treated group between three months and one year following randomization, the study failed to meet the primary endpoint of a significant improvement in overall survival through at least ninety-one days assessed using the Kaplan Meier statistical method. The secondary endpoint of the proportion of survivors at study day ninety-one also showed no statistically significant difference between the groups.
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. Consequently, the Company has ceased any further development of the ELAD System and is exploring strategic options.
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