EnteroBiotix Reports Positive Results from Phase 1b IMPuLCE Study of EBX-102 in Liver Cirrhosis

Overview

EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, announced positive results from its phase 1b IMPuLCE study evaluating EBX-102 in patients with liver cirrhosis.

About EnteroBiotix

• EnteroBiotix’s first-in-human study of EBX-102 was a randomised, double-blind, placebo-controlled Ph1b study of adult participants with stable liver cirrhosis. 
• It was designed to evaluate the safety, tolerability, and translational biomarker effects of two different doses of EBX-102. 
• The study was conducted across ten sites in the United Kingdom. 
• Participants were followed up for 12 weeks after dosing.

Words from the CEO: EnteroBiotix

Dr James McIlroy MBChB, CEO of EnteroBiotix, said: “We wish to thank the participants and the investigators for making this study possible and for their contributions to enable the development of EBX-102. In addition to safety and tolerability data supporting further studies, we observed multiple microbiome and systemic measurements supporting mechanistic proof-of-principle. There are very large unmet medical needs in the field of advanced liver disease, and it is greatly encouraging that EBX-102 has potential efficacy in this population.

Data Highlights:

• EBX-102 was well tolerated with an acceptable safety profile. The commonest adverse events were gastrointestinal, and mainly mild and self-limiting. No serious treatment emergent adverse events were reported.
• Participants receiving the higher dose of EBX-102 in Cohort 2 showed significant shifts in stool bacterial microbiome composition compared to placebo, assessed by 16SrRNA sequencing.
• Participants receiving EBX-102 showed statistically significant changes to stool bacterial metabolites. Shotgun sequencing is ongoing and will provide additional insights into engraftment.

Venous Ammonia Concentrations in All Volunteers

• Venous ammonia concentrations remained stable in all study participants, whereas there was a statistically significant increase in stool ammonia concentrations in the treatment groups but not the placebo group. 
• This suggests a shift towards enhanced ammonia excretion through the stool rather than absorption into the bloodstream.
• A reduction in plasma lipopolysaccharide-binding protein (LBP) was observed in the drug cohorts but not in the placebo. 
• This may indicate successful modulation of the gut microbiota towards a more beneficial ecology, improved gut barrier integrity, and a reduced inflammatory response.

An improvement in hospital anxiety and depression scores were observed in the treatment groups but not in the placebo group, with a stronger trend at the higher dose, indicating potential gut-brain-axis effects.

From Chief Investigator of the IMPuLCE Study

• Professor Ewan Forrest, chief investigator of the IMPuLCE study and Honorary Professor, School of Cardiovascular & Metabolic Health at the University of Glasgow commented: “These exciting data demonstrate that EBX-102 is well tolerated in patients with chronic liver disease, showing promising biological effects that strongly support further clinical development. 
• The observed improvement in mental health scores is particularly intriguing, and we look forward to continuing to explore the potential of EBX-102 in future liver disease trials.

About EBX-102

• EBX-102 is an encapsulated full-spectrum microbiome therapeutic with differentiated characteristics, such as consistency, high-bacterial diversity, and stability. 
• EnteroBiotix has platform manufacturing technologies and a well-developed analytical toolkit that enable the scalable manufacture of EBX-102. 
• The company 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.

About the Company: EnteroBiotix

• EnteroBiotix is a clinical-stage biotechnology company developing therapeutics to treat gastrointestinal and hepatic diseases. 
• EnteroBiotix’s therapies contain highly diverse ecosystems of microorganisms stabilised using proprietary platform technology and designed to improve gut health by augmenting the gut microbiome.