ELAD system for acute liver failure fails Phase III trial.- Vital Therapeutics
Vital Therapeutics halted development of its Extracorporeal Liver Assist System (ELAD) for acute forms of liver failure, which failed its pivotal trial, and will explore strategic options. The announcement followed the extracorporeal human allogeneic cell therapy�s failure in a Phase III trial in patients with severe alcoholic hepatitis. ELAD failed the VTL-308 pivotal study (NCT02612428) by failing to achieve the study�s primary endpoint of a significant improvement in overall survival through at least 91 days assessed using the Kaplan Meier statistical method.
The trial�s secondary endpoint of proportion of survivors at study day 91 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 U.S. or EU, if ever, without additional clinical trials that would require substantial capital and time to complete.
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