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news.Vital Therapies (VTL), a biotherapeutic company developing ELAD, a cell-based therapy targeting the treatment of liver failure, today announced that topline results from VTI-208, the Company's phase 3 randomized, 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.
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Of 203 total subjects enrolled in VTI-208, 96 were randomized to the treated group and 107 were randomized to the control group. A hazard ratio of 1.027 (slightly favoring the control group) with a log rank p-value of 0.90 (not statistically significant, N.S.) 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 (N.S.) and 0.74 (N.S.), 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 analyzing the entire data set in accord with the statistical analysis plan submitted to FDA prior to database lock. Preliminary findings, which remain to be confirmed, include the following:
In a 120-subject, pre-specified exploratory subset of the intention-to-treat, or ITT, population with a MELD score of <28 at randomization, a Kaplan-Meier analysis of overall survival approached statistical significance with a hazard ratio of 0.575 and a log-rank p-value of 0.077 (N.S.) in favor of the ELAD group. In the per protocol population for this subset (N = 116), the p-value was 0.059 (N.S.). Furthermore, an analysis of 91-day survival in the ITT cohort revealed ELAD survival of 80.4% versus control survival of 65.2% (Pearson’s chi-squared p=0.068, (N.S.)).
In subjects with MELD scores of >28 at baseline, outcomes appeared to be worse in the ELAD group compared with the Control group, (p=N.S.), suggesting that future clinical studies should exclude subjects with MELD scores >28. In other respects the ELAD and Control groups appear to be balanced with regard to baseline demographics and key measures of liver disease.