EnteroBiotix Reports Positive Phase 2a Results for IBS Treatment EBX-102-02

GLASGOW, Scotland, March 18, 2025 – EnteroBiotix Limited, a biopharmaceutical company specializing in gut health, has announced promising preliminary outcomes from their TrIuMPH Phase 2a clinical trial, which examined EBX-102-02, a new microbiome-based treatment for irritable bowel syndrome with constipation (IBS-C). This study is significant for those seeking innovative solutions to gastrointestinal disorders.

The TrIuMPH study, a multicenter, randomized, double-blind, placebo-controlled trial, evaluated the safety and initial efficacy of EBX-102-02 in 122 adults with moderate to severe IBS-C and IBS with diarrhea (IBS-D). Participants were divided into two groups, with a 2:1 ratio of receiving either EBX-102-02 or a placebo. The treatment involved two dosages of eight capsules each, administered on the first and seventh days, with follow-up extending over six weeks.

In the IBS-C subgroup, which consisted of 62 participants, EBX-102-02 showed clinically significant improvements in key measures such as the IBS Symptom Severity Score (IBS-SSS), stool consistency, frequency of complete bowel movements, and abdominal pain relief. These benefits were detected as early as the first week and persisted throughout the monitoring period. The efficacy of EBX-102-02 was notably better than that of the placebo, suggesting its potential as a therapeutic option for IBS-C sufferers.

The treatment was well-tolerated, with most adverse effects being mild and related to the gastrointestinal system. There were no cases of severe diarrhea or serious adverse events. Additionally, metagenomic analysis indicated a considerable alteration in the gut microbiota of those treated with EBX-102-02, aligning their microbiota composition more closely with that of the treatment itself, a change that was maintained during follow-up.

EnteroBiotix plans to release comprehensive data, including results from the IBS-D cohort, by the third quarter of 2025. The company is in discussions with regulatory bodies about advancing the clinical development of EBX-102-02 for IBS treatment, with intentions to initiate a larger Phase 2b trial to validate these findings.

Paul Goldsmith, MD, FRCS, the Chief Investigator of the TrIuMPH study and a Consultant General Surgeon at the University of Manchester NHS Trust, noted the significance of the findings, highlighting the potential of EBX-102-02 as a pioneering treatment for IBS. Yan Yiannakou, a Consultant Neurogastroenterologist, also expressed optimism about the trial's results, emphasizing the urgent need for innovative treatments in this area and supporting the continued development of EBX-102-02.

EnteroBiotix's CEO, Dr. James McIlroy, articulated the company's commitment to advancing IBS treatment options, underscoring the importance of these results in progressing towards a much-needed solution for patients. The achievements in this study build on previous successes in related research fields, particularly in liver cirrhosis.

EnteroBiotix is dedicated to developing microbiome-based treatments for gastrointestinal and liver diseases, leveraging its proprietary platform technology to create advanced therapies that enhance gut health. The company manages its supply chain and manufacturing, ensuring the quality and efficacy of its products. EBX-102-02, their innovative microbiome product, is formulated as a stable, high-diversity microbiome consortium intended to offer rapid and effective relief for symptoms associated with gut microbiome-related conditions, including IBS.

The Functional Gut Clinic, a major partner in this trial, is renowned for its expertise in gastrointestinal diagnostic services in the UK. Established in 2013, it is accredited for quality and plays a pivotal role in researching and testing new digestive health solutions.