EnteroBiotix Limited, a biotechnology company focused on advancing microbiome therapeutics, has announced positive Phase 1b results for its flagship treatment, EBX-102, targeting liver cirrhosis.
The IMPuLCE study, designed as a randomized, double-blind, placebo-controlled trial, aimed to evaluate the safety, tolerability, and biomarker efficacy of EBX-102 in adults with stable liver cirrhosis.
Conducted across ten sites in the United Kingdom, the study followed participants for 12 weeks, delivering promising findings.
Positive shifts in microbiome and systemic health indicators
Dr. James McIlroy, CEO of EnteroBiotix, expressed gratitude towards participants and study investigators, highlighting the significance of these results. “The data from the study indicate not only safety and tolerability but also a strong proof-of-principle in terms of microbiome and systemic health indicators. The potential of EBX-102 to address the large unmet needs in liver disease is a critical step forward in our mission,” McIlroy stated.
Key outcomes from the study showed EBX-102 was well tolerated, with the most common adverse events being mild, transient gastrointestinal symptoms. Importantly, no serious adverse events emerged. Patients receiving the higher dose of EBX-102 displayed notable shifts in gut microbiome composition, as evidenced by 16S rRNA sequencing, which were not observed in the placebo group.
Gut-Brain Axis and microbiome modulation: pioneering advances
Additional findings pointed to the potential of EBX-102 to impact gut-brain health. In the treatment groups, hospital anxiety and depression scores improved, particularly in those receiving higher doses. This promising result aligns with broader research into the gut-brain axis and highlights EBX-102’s potential beyond liver function, suggesting a positive impact on mental well-being.
Further analysis showed that treatment groups had stable venous ammonia levels and increased stool ammonia concentrations, implying enhanced ammonia excretion. A reduction in plasma lipopolysaccharide-binding protein (LBP) was observed, suggesting improvements in gut barrier integrity and a reduced inflammatory response, both critical factors for patients with liver cirrhosis.
Professor Ewan Forrest, Chief Investigator of the IMPuLCE study and Honorary Professor at the University of Glasgow, shared his optimism: “These findings highlight EBX-102’s potential in managing chronic liver disease. The observed mental health improvements are particularly intriguing, and we are excited to continue exploring these effects in future trials.”
About EBX-102 and EnteroBiotix
EBX-102, EnteroBiotix’s full-spectrum microbiome therapeutic, stands out due to its high bacterial diversity, stability, and encapsulated formulation. Supported by robust manufacturing technology, EBX-102 promises consistency and scalability. EnteroBiotix has also established a supply chain management system through MHRA-licensed manufacturing infrastructure and the Number 2® brand, ensuring quality and safety.
This promising Phase 1b data places EBX-102 at the forefront of microbiome therapeutics for liver disease. EnteroBiotix is now pursuing further studies in liver disease and expanding its research into other conditions, including irritable bowel syndrome (IBS) and allo-HSCT in partnership with Imperial College London.
As microbiome-based treatments advance, EBX-102 represents a potential breakthrough for patients with liver cirrhosis, supporting the continued development of microbial therapeutics as transformative health solutions.
