EnteroBiotix announces positive trial results for IBS therapeutic
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.