EBX-102-02 Shows Benefit for IBS-C and IBS-D in Phase 2a TrIuMPH Trial

EnteroBiotix Limited has 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 diarrhea (IBS-D).1

As described in a January 8, 2026, release from the Company, in the TrIuMPH study of 122 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 6-week follow up period in both the IBS-C and IBS-D cohorts.1

“IBS is a complex disease with a significant unmet medical need,” Paul Goldsmith MD, Consultant General Surgeon at the University of Manchester NHS Trust and Chief Investigator of the TrIuMPH study, said in a statement.1 “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.”

EBX-102-02 is a 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. EBX-102-02 is not yet approved in any jurisdiction for clinical therapeutic use unless in a clinical trial or regulated program.1

TrIuMPH was a UK-based, multicenter, 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). Participants were randomly assigned in a 2:1 ratio to receive EBX-102-02 (8 capsules on day 1 and day 7) or matched placebo and were followed for 6 weeks after the first dose.1

Study outcomes included safety and tolerability, IBS-SSS, bowel habit diaries, validated patient-reported outcome measures, and changes in gut microbiome structure and function.1

Data from the IBS-C arm of the trial were presented during a late-breaking session at Digestive Disease Week (DDW) 2025 by Anthony Hobson, MPhil, PhD, clinical director and senior clinical GI scientist at The Functional Gut Clinic and founder of Tummy MOT, and showed EBX-102-02 was safe, tolerable, and led to improvements in IBS-SSS, abdominal pain, and stool consistency.2

Final results for both cohorts showed EBX-102-02 demonstrated clinically meaningful improvements, defined as a ≥50-point reduction, in the IBS-SSS in both IBS-C and IBS-D, with improvements observed as early as week 1 and sustained through week 7 and greater reductions versus placebo at all measured timepoints.1

In a post-hoc responder analysis, 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.1

Investigators noted 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.1

EBX-102-02 was generally well tolerated, with adverse events 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.1

Additional 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, changes that were observed in both IBS-C and IBS-D and were maintained through follow-up.1

“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,” James McIlroy, CEO of EnteroBiotix, said in a statement.1 “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.”

References

1. EnteroBiotix. 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. https://www.globenewswire.com/news-release/2026/01/08/3215080/0/en/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.html

2. McIlroy J, Hobson A. EBX-102-02, A Full-Spectrum Microbiome Drug, Shows Promise for IBS-C in Phase 2a Trial. HCPLive. May 6, 2025. Accessed January 8, 2025. https://www.hcplive.com/view/ebx-102-02-full-spectrum-microbiome-drug-shows-promise-ibs-c-phase-2a-trial