ELAD System fails to meet primary endpoint of Phase III trial in alcohol-induced liver decompensation- Vital Therapies

Vital Therapies announced that topline results from VTI 208, the company's Phase III randomised, controlled, open-label trial, evaluating the ELAD System in subjects with alcohol-induced liver decompensation (AILD) failed to meet the primary endpoint of overall survival through at least 91 days assessed using the Kaplan-Meier statistical method. Of 203 total subjects enrolled in VTI-208, 96 were randomised to the treated group and 107 were randomised to the control group. A hazard ratio of 1.027 (slightly favouring the control group) with a log rank p-value of 0.90 (not statistically significant, NS) indicated that there was no difference between treated and control subjects in the primary endpoint.

The secondary endpoints of proportion of survivors at study days 28 and 91 also showed no difference between the groups (Pearson's Chi-squared p-values of 0.45 (NS) and 0.74 (NS), respectively). The adverse event profile revealed that treatment emergent serious adverse events were similar between the treated and control groups in the predefined safety population. The company is still in the process of analysing the entire data set in accord with the statistical analysis plan submitted to FDA prior to database lock.