YAQ-001. Randomised, placebo-controlled trial of oral Yaq-001 in decompensated cirrhosis

Several lines of evidence have implicated translocated bacterial products such as endotoxin in the pathogenesis of decompensated cirrhosis. Current interventional strategies to modulate this process are limited to oral antibiotics with the attendant risk of superinfection and antimicrobial resistance. Yaq-001 is a novel synthetic carbon with a high adsorptive capacity for biologically relevant pathogenic mediators such as endotoxin and cytokines. Preclinical studies in models of cirrhosis demonstrated oral Yaq-001 administration was associated with reduced endotoxin sensitivity, portal pressure, inflammatory indices, and markers of liver injury. This first-in-man phase 2 study met its primary end point of demonstrating safety and tolerability of Yaq-001 carbon in decompensated cirrhosis. The data suggests a proof of mechanism that endotoxin-binding Yaq-001 improves intestinal and systemic inflammation, beneficially modulates the gut microbiome, and promotes improvement in gut health.