EBX-102-02, A Full-Spectrum Microbiome Drug, Shows Promise for IBS-C in Phase 2a Trial

New phase 2a data suggest EBX-102-02, a next-generation oral full-spectrum microbiome drug, is safe, tolerable, and leads to improvements in IBS-Symptom Severity Scale (IBS-SSS), abdominal pain, and stool consistency in patients with irritable bowel syndrome with constipation (IBS-C).1,2

Findings from the Treating IBS with an Intestinal Microbiota Product for Health (TrIuMPH) 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.1

“What we're essentially trying to do is reconstruct the microbiome in a very dramatic and complete way, so reinstating any missing constituents and displacing potentially bad actors that are driving the pathogenesis and symptomatology in those patients,” James McIlroy, MBChB, BMedSci, founder and CEO of EnteroBiotix, explained to HCPLive.

TrIuMPH sought to evaluate EBX-102-02’s safety and tolerability in patients with IBS-C and to assess its effects on daily bowel habits, IBS symptoms, quality of life, breath tests, and the gut microbiome. The trial enrolled patients with IBS-C, confirmed by Rome IV grading criteria and IBS-SSS inclusion of ≥ 175, and randomly assigned them in a 2:1 active to placebo ratio.1

Participants received 2 doses of EBX-102-02, with 8 capsules at each dosing, or placebo, 1 week apart. Visits occurred at baseline, week 1, week 3, and week 7 to assess safety, IBS-SSS, IBS-QoL, PAC-SYM, and methane production. Patients completed a daily bowel habit diary throughout follow-up, and stool samples were collected at each visit for metagenomic sequencing of the microbiome and targeted metabolomics.1

The results presented at DDW were based on the first raw data set of the trial and included 62 participants who underwent randomization, 61 (98%) of whom completed follow-up. While the most common adverse events were mild, self-limited, and gastrointestinal in nature, a single treatment-emergent adverse event, vomiting, led to participant withdrawal.1

Results showed EBX-102-02 group mean IBS-SSS scores decreased by 68 between baseline and week 3 and 78 between baseline and week 7. Placebo group mean IBS-SSS scores decreased by 34 between baseline and week 3 and 53 between baseline and week 7.1

Investigators noted the mean severity of abdominal pain in the last 10 days measured by IBS-SSS reduced by 14.1 between baseline and week 7 in the EBX-102-02 group and reduced by 9.3 in the placebo group. The mean percentage of stool BSFS 1 or 2 at was 69% at baseline and decreased to 30% at week 3 in the EBX-102-02 group, while in the placebo group, the mean percentage of stool BSFS 1 or 2 at was 67% at baseline and 54% at week 3.1

Of note, the fecal microbiota composition of patients who received EBX-102-02 became more like the composition of EBX-102-02, and this persisted up to week 7 of follow-up.1

“Just after doing the IBS-C trial, we did IBS-D as well. We're just analyzing those data too, and that's going to be exciting to see whether it works across the spectrum,” Hobson told HCPLive, additionally describing plans to conduct a larger, longer study in more patients with IBS-C with an extra dose of the product.

References

1. Craven LJ, Smyth MDL, Howard L, et al. A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II TRIAL ASSESSING THE SAFETY AND EFFICACY OF EBX-102-02, AN ORAL FULL-SPECTRUM INTESTINAL MICROBIOTA PRODUCT, IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION; THE TRIUMPH TRIAL. Abstract presented at Digestive Disease Week 2025 in San Diego, CA, from May 3 - May 6, 2025.

2. EnteroBiotix. EnteroBiotix Presents Positive IBS-C Data at Digestive Disease Week® 2025. May 6, 2025. Accessed May 6, 2025. https://www.enterobiotix.com/news/positive-ibs-c-data-2025