EnteroBiotix Presents Positive Data in Liver Cirrhosis at EASL 2025
- EBX-102 was well tolerated and showed multiple positive trends over placebo
- Findings support progression to a Phase 2b trial
Glasgow, Scotland – 13 May 2025. EnteroBiotix Limited (‘EnteroBiotix)’ a clinical-stage biotechnology company developing best-in-class therapies for gut health, today announced positive results from its Phase 1b clinical trial evaluating EBX-102, the Company’s next-generation oral full-spectrum microbiome product, in patients with liver cirrhosis. The data were presented during an oral session at the European Association for the Study of the Liver (EASL) Congress 2025, held in Amsterdam, the Netherlands from 7–10 May 2025.
The IMPuLCE (Intestinal Microbiota Product in Liver Cirrhosis and Encephalopathy) trial evaluated two ascending doses of EBX-102 in 24 patients with stable cirrhosis. Headline data were first announced in November 2024, and key findings presented at EASL included:
- Safety and tolerability: EBX-102 was well tolerated. Adverse events were mainly mild, self-limiting, and gastrointestinal in nature
- Microbial engraftment: Shotgun metagenomic sequencing showed that engraftment of EBX-102 species occurred in both treatment cohorts across all measured timepoints. EBX-102 treatment also led to changes in microbiome-associated metabolic outputs, including short-chain fatty acids and secondary bile acids
- Clinical and bioanalytical trends: Patients treated with EBX-102 demonstrated decreased venous ammonia and increased stool ammonia concentrations in the high-dose cohort. Reductions in plasma lipopolysaccharide binding protein (LBP) – a marker of bacterial translocation and gut barrier function – were observed in the higher dose cohort. Additionally, Hospital Anxiety and Depression Scale (HADS) scores improved in patients receiving EBX-102, with trends persisting in the higher dose group to the end of follow-up
Professor Ewan Forrest, Chief Investigator of the IMPuLCE trial and Honorary Professor, School of Cardiovascular & Metabolic Health at the University of Glasgow, said: “These positive initial results show that EBX-102 was well tolerated in patients with chronic liver disease. The observed EBX-102 species engraftment and positive clinical and bioanalytical trends are highly promising. These findings strongly support further clinical development of EBX-102 in decompensated liver cirrhosis, where it has the potential to become a first-in-class therapy.”
Dr. James McIlroy, CEO of EnteroBiotix, added: “These positive Phase 1b results highlight the potential of EBX-102 as a novel therapeutic approach for patients with hepatic diseases, including liver cirrhosis. We look forward to progressing into Phase 2b clinical studies in patients with more advanced cirrhosis.”
This presentation of significant results in liver cirrhosis follows EnteroBiotix’s recent presentation of positive results in irritable bowel syndrome with constipation (IBS-C) at Digestive Disease Week 2025.
About EnteroBiotix
EnteroBiotix is a clinical-stage biotechnology company developing microbiome-based therapeutics for irritable bowel syndrome (IBS) and other gastrointestinal and hepatic indications. Using its proprietary platform technology, EnteroBiotix creates next-generation therapies with differentiated characteristics designed to restore and enhance gut microbiome function. The company has established independent control over the supply chain for its drug formulations, with MHRA licensed manufacturing capabilities, and a donor programme called Number2®.
About EBX-102
EBX-102 is an encapsulated full-spectrum microbiome therapeutic with differentiated characteristics, such as consistency, high-bacterial diversity, and robust stability. EnteroBiotix controls the supply chain for its products through sophisticated MHRA-licensed manufacturing infrastructure together with its Number 2® brand, which ensures the safety, security, quality, and sufficiency of supply of microbiota obtained from healthy human donors.
Media contacts
EnteroBiotix
Dr James McIlroy, CEO
info@enterobiotix.com
ICR Healthcare
Namrata Taak, Kris Lam
enterobiotix@ICRHealthcare.com
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