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)

This study is focused on a serious liver condition called Acute-on-Chronic Liver Failure (ACLF). This happens when a long-term liver problem suddenly gets much worse. It's a very worrying condition where the liver struggles to do its job, and other parts of the body can also be affected. When the liver isn't working properly, harmful substances like ammonia can build up in the body. This can lead to a complication called Hepatic Encephalopathy, which affects the brain and can make you feel confused or drowsy. ACLF is a major concern for people with cirrhosis (severe liver scarring) and can be life-threatening.

The main goal of this study is to test a new treatment called VS-01. We want to see if adding VS-01 to the usual care for ACLF patients makes a difference. The study is particularly looking at patients with different levels of ACLF, from milder (grade 1) to more severe (grade 3a). By comparing the effects of VS-01 plus standard care to standard care alone, researchers hope to understand if this new treatment can improve how patients recover, help their liver get better, and ultimately save lives.

This is a 'Phase 2a' study, which means it's an early stage of research. It's designed to explore whether VS-01 is safe and if there are signs that it could be an effective treatment for ACLF. If the results are promising, it could lead to larger studies in the future, bringing us closer to better treatments for this serious liver condition.