A Phase 2a, open-label, randomized, controlled, multi-center, proof of concept study, to assess the efficacy, safety, and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF)

2 or 3a patients., Acute-on-chronic liver failure (ACLF) is characterized by hepatic and extrahepatic organ dysfunction and/or failure and highly activated systemic inflammation. It leads to an accumulation of different metabolites, interalias ammonia, which cannot be metabolized. Hyperammonemia leads to Hepatic Encephalopathy (HE). ACLF is a major cause of death in cirrhosis, with an approximately 50% mortality rate. The selected patient population is ACLF grade 1

CLIF-C ACLF score at Day 7

Outcome a) 90 day – mortality; b) 28 day – mortality; c) Time to death through Day 90; d) Time to death through Day 28; e) Change in ACLF grade through/at Days 7 and 28: - Rate of ACLF resolution; - Time to ACLF resolution; - Rate of ≥ one ACLF grade regression; - Time to ≥ one ACLF grade regression; f) Transplant-free survival through/at Day 90; g) Transplant-free survival through/at Day 28, Safety a) Incidence rate, severity, and relationship to VS-01 of adverse drug reactions and serious adverse drug reactions.

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