A Phase 2, Randomized, Controlled, Open Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy

Patients with overt hepatic encephalopathy (OHE) and acute decompensation (AD) of liver cirrhosis or acute-on chronic liver failure (ACLF) grade 1

Time to improvement of OHE as assessed by HEGI. Improvement is defined as: a) A reduction of HE grades 4 or 3 to grade ≤2, or b) A reduction of HE grade 2 to grade <2.

Safety and tolerability defined as: a) The incidence and severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0 grade) of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), comprising the evaluation of vital signs, ECG parameters, and laboratory parameters., PK/PD: a) PK (for active treatment arms): blood and peritoneal fluid concentration-time profile of BL-corrected citric acid and lipids in patients treated with VS-01. b) PD (for all arms): change from BL in fasting blood and peritoneal fluid ammonia levels.

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