EnteroBiotix announces positive Phase 2 TrIuMPH results supporting EBX-102-02 as a potential first-in-class, oral, full-spectrum microbiome therapy for irritable bowel syndrome
EnteroBiotix announces positive Phase 2 TrIuMPH results supporting EBX-102-02 as a potential first-in-class, oral, full-spectrum microbiome therapy for irritable bowel syndrome
- Clinically meaningful improvements in global IBS symptom severity observed as early as Week 1 and sustained through Week 7, with EBX-102-02 outperforming placebo throughout the study (final assessment at Week 7)
- Durable improvements observed across abdominal pain, bowel habit parameters and IBS-specific quality of life, with benefit demonstrated in both constipation and diarrhoea-predominant IBS
- EBX-102-02 was well tolerated, with no serious drug-related adverse events reported
GLASGOW, Scotland, Jan. 08, 2026 (GLOBE NEWSWIRE) — EnteroBiotix Limited (“EnteroBiotix”), a clinical-stage biopharmaceutical company focused on developing best-in-class therapies for gut health, today announced positive final results from TrIuMPH, a Phase 2a clinical trial evaluating EBX-102-02, a next-generation oral full-spectrum microbiome therapeutic, in patients with irritable bowel syndrome with constipation (IBS-C) or diarrhoea (IBS-D).
In the TrIuMPH study of 122 UK patients, EBX-102-02 demonstrated clinically meaningful improvements in the IBS symptom severity score (IBS-SSS) versus placebo, with clear separation from placebo observed as early as week 1 and sustained throughout the six-week follow up period. Benefits were observed across key assessments, including abdominal pain, bowel habit parameters, and IBS-specific quality of life. Importantly, clinically meaningful improvements in IBS-SSS that were superior to placebo were observed at all measured time points in both IBS-C and IBS-D populations, supporting the potential of EBX-102-02 as a single therapeutic approach for two major disease subtypes.
These results build on the previously reported positive topline data from the IBS-C cohort reported in March 2025 as a late-breaking oral presentation at Digestive Disease Week in San Diego. The full dataset extends the evidence base for EBX-102-02 across both IBS-C and IBS-D subtypes, supporting its development as a potential first-in-class therapeutic. EnteroBiotix plans to submit the full TrIuMPH dataset for peer-reviewed scientific publication and to initiate an IBS-C Phase 2b study in 2026, aligned with recent FDA regulatory advice.
Dr James McIlroy, CEO of EnteroBiotix, said: “The final TrIuMPH data demonstrate that EBX-102-02 has the potential to be a first-in-class, orally delivered, full-spectrum microbiome therapeutic for IBS, delivering clinically meaningful and durable improvements across multiple symptom domains in both IBS-C and IBS-D. Combined with a favourable safety profile and clear evidence of microbiome ecosystem restoration, these results strongly support advancement into our planned Phase 2b clinical trial with the goal of delivering a transformative treatment for patients with IBS.”
Mr Paul Goldsmith MD, FRCS, Consultant General Surgeon at the University of Manchester NHS Trust and Chief Investigator of the TrIuMPH study, said: “IBS is a complex disease with a significant unmet medical need. The improvements in global symptom severity, abdominal pain, bowel habits and quality of life observed with EBX-102-02 in this study are clinically meaningful. Taken together, these data support continued development of EBX-102-02 across both IBS-C and IBS-D.”
Study design
TrIuMPH was a UK-based, multicentre, randomised, double-blind, placebo-controlled Phase 2a study enrolling 122 adults with moderate-to-severe IBS, including IBS-C (n=62) and IBS-D (n=60). The study is registered as ISRCTN65517362 (“Treating IBS with an Intestinal Microbiota Product for Health”). TrIuMPH was delivered with support from the Functional Gut Clinic (FGC).
Participants were randomised 2:1 to receive EBX-102-02 (8 capsules on Day 1 and Day 7) or matched placebo and were followed for six weeks after the first dose. Study outcomes included safety and tolerability, IBS-SSS, bowel habit diaries, validated patient-reported outcome measures, and changes in gut microbiome structure and function. Post-hoc analyses included responder assessments.
Efficacy results
IBS symptom severity (IBS-SSS)
EBX-102-02 demonstrated clinically meaningful improvements (≥50-point reduction) in the IBS symptom severity score in both IBS-C and IBS-D. Improvements were observed as early as Week 1 and were sustained through Week 7, with greater reductions versus placebo at all measured timepoints.
Responder analysis (post-hoc)
Using a ≥50-point IBS-SSS reduction threshold, 59% of patients treated with EBX-102-02 were responders at Week 7 compared with 44% on placebo across the overall IBS population. Using a more stringent ≥75-point reduction threshold, responder rates were 51% versus 33%, respectively.
Key symptom domains
Improvements were observed across abdominal pain, bowel habit parameters and IBS-specific quality of life in both IBS-C and IBS-D cohorts, consistent with a broad, multi-domain therapeutic effect.
Safety and tolerability
The primary endpoint of the TrIuMPH study was safety. EBX-102-02 was generally well tolerated. Adverse events were primarily mild-to-moderate, self-limiting and gastrointestinal in nature. No severe or serious drug-related adverse events were reported, and no safety signals of concern were identified in either cohort. The safety profile was consistent with that observed in the Company’s IMPuLCE Phase 1b study in liver cirrhosis.
Microbiome analysis
Preliminary shotgun metagenomic sequencing demonstrated that EBX-102-02 induced a broad and sustained shift in the gut microbiome towards the composition of the administered product. These changes were observed in both IBS-C and IBS-D and were maintained through follow-up.
About EnteroBiotix
EnteroBiotix is a clinical-stage biopharmaceutical company developing microbiome-based therapies for gastrointestinal and metabolic diseases. Using proprietary manufacturing and analytical technologies, the Company aims to create best-in-class orally delivered products that comprehensively restore microbial ecology and function. EnteroBiotix is headquartered in Glasgow, Scotland.
About EBX-102-02
EBX-102-02 is EnteroBiotix’s next-generation full-spectrum microbiome therapeutic, manufactured using proprietary processing technologies that enable safe, stable and orally delivered microbial ecosystem restoration. It is designed to deliver consistently high microbial diversity with a robust stability profile. It is not approved in any jurisdiction for clinical therapeutic use unless in a clinical trial or regulated programme.
About the Functional Gut Clinic
The Functional Gut Clinic (FGC) is the UK’s leading provider of Functional GI Diagnostic Testing with three UK clinic sites in London, Manchester and Cambridge. FGC provides both private and NHS services to 1000’s of patients around the UK and is the only independent GI physiology clinic to have Improving Quality in Physiological Services (IQIPS) / United Kingdom Accreditation Services (UKAS) and Care Quality Commission (CQC) accreditation. Established in 2013, FGC has an extensive R&D and Clinical trials portfolio helping to design and test future digestive health tests, treatments and devices.
Media contacts
EnteroBiotix
Dr James McIlroy, CEO
info@enterobiotix.com
