EBX-102 demonstrated proof-of-principle across multiple microbiome assessments, inflammatory biomarkers and clinical assessments, supporting its continued development as the first microbial therapy for individuals with liver disease
Glasgow, Scotland - 11 November 2024. EnteroBiotix Limited ('EnteroBiotix' or the 'Company'), a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced positive results from its Phase 1b IMPuLCE study evaluating EBX-102 in patients with liver cirrhosis.
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.
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 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.
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 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.
EnteroBiotix is currently enrolling patients in a Ph2 double-blind, placebo-controlled, multi-centre clinical study in irritable bowel syndrome (IBS) and is progressing a Ph2a study with Imperial College in patients undergoing allo-HSCT.
Media contacts
EnteroBiotix
Dr James McIlroy MBChB, CEO
info@enterobiotix.com
ICR Healthcare
Namrata Taak, Kris Lam
enterobiotix@ICRHealthcare.com
