EnteroBiotix Presents Positive IBS-C Data at Digestive Disease Week® 2025
Ph2b trial in IBS-C initiating in H2 2025 to confirm efficacy
Glasgow, Scotland – 6 May 2025. EnteroBiotix Limited ('EnteroBiotix'), a biopharmaceutical company developing best-in-class therapies for gut health, today presented positive data from its TrIuMPH Phase 2a trial evaluating EBX-102-02, the Company's next-generation oral full-spectrum microbiome product, in patients with irritable bowel syndrome with constipation (IBS-C) at Digestive Disease Week® (DDW) 2025, taking place 3–6 May in San Diego, USA.
The multicentre, randomised, double-blind, placebo-controlled TrIuMPH trial evaluated the safety, tolerability, and efficacy of EBX-102-02 in 122 patients with moderate to severe irritable bowel syndrome with constipation (IBS-C) or diarrhoea (IBS-D). Participants were randomised 2:1 to receive 8 capsules of EBX-102-02 on Day 1 and Day 7 or matched placebo, with follow-up through Week 6. Data presented at DDW focused on the IBS-C cohort; results from the IBS-D cohort are expected in Q2 2025.
EBX-102-02 was well tolerated, with adverse events primarily mild, self-limiting, and gastrointestinal in nature. Patients receiving EBX-102-02 showed clinically meaningful improvements and favourable trends compared to placebo across multiple endpoints, including the IBS Symptom Severity Score (IBS-SSS), abdominal pain, stool consistency, straining severity, average weekly complete bowel movements, PAC-SYM, and IBS Quality of Life (IBS-QoL). Improvements were observed as early as Week 1 and were sustained through follow-up.
Shotgun metagenomic sequencing demonstrated robust strain engraftment, with the microbiome profiles of treated patients shifting toward the composition of the EBX-102-02 product.
Highlights from the TrIuMPH trial presented at DDW 2025 included: IBS-SSS: Patients receiving EBX-102-02 showed greater improvement in IBS-SSS than placebo across all measured timepoints, with mean reductions of 78 points compared to 53 in the placebo group by Week 7.
Patients receiving EBX-102-02 showed greater improvement in IBS-SSS than placebo across all measured timepoints, with mean reductions of 78 points compared to 53 in the placebo group by Week 7. Abdominal Pain: Mean abdominal pain severity dropped by 14.1 points in the EBX-102-02 group compared to 9.3 in the placebo group by Week 7. There was an improvement in the number of days with reported abdominal pain, with a 2.0 day reduction in the EBX-102-02 compared to 1.1 day reduction in the placebo group at Week 7.
Mean abdominal pain severity dropped by 14.1 points in the EBX-102-02 group compared to 9.3 in the placebo group by Week 7. There was an improvement in the number of days with reported abdominal pain, with a 2.0 day reduction in the EBX-102-02 compared to 1.1 day reduction in the placebo group at Week 7. Bristol Stool Form: The weekly average number of stools classified as hard (BSFS 1 or 2) fell from 69% to 30% in the EBX-102-02 group compared to a decrease from 67% to 54% with placebo by Week 3.
The weekly average number of stools classified as hard (BSFS 1 or 2) fell from 69% to 30% in the EBX-102-02 group compared to a decrease from 67% to 54% with placebo by Week 3. Complete Bowel Movement Frequency : Patients receiving EBX-102-02 experienced greater improvement in complete bowel movements than those on placebo, with an average increase of over one bowel movement per week in 4 out of 6 follow-up weeks, compared to 2 out of 6 weeks in the placebo group.
: Patients receiving EBX-102-02 experienced greater improvement in complete bowel movements than those on placebo, with an average increase of over one bowel movement per week in 4 out of 6 follow-up weeks, compared to 2 out of 6 weeks in the placebo group. Microbiome Shift Toward Product Composition: Faecal microbiota profiles in the EBX-102-02 group shifted toward the composition of the drug product and this effect persisted through Week 7.
Dr. James McIlroy MBChB, CEO of EnteroBiotix, commented: 'These positive data in EBX-102-02 for IBS-C represent a significant milestone for EnteroBiotix and for the broader field of microbiome-based therapeutics. EBX-102-02 was well tolerated and demonstrated consistent, clinically meaningful improvements across multiple IBS symptoms and measurements of quality of life. The observed microbial engraftment reinforces our confidence our full-spectrum approach. We look forward to advancing EBX-102-02 into a Ph2b trial later this year and were pleased to discuss these data with our Scientific Advisory Board during the Conference.'
About EnteroBiotix
EnteroBiotix is a clinical-stage biotechnology company developing microbiome-based therapeutics for irritable bowel syndrome (IBS) and other gastrointestinal and hepatic indications. Using its proprietary platform technology, EnteroBiotix creates next-generation therapies with differentiated characteristics designed to restore and enhance gut microbiome function. The company has established independent control over the supply chain for its drug formulations, with MHRA licensed manufacturing capabilities, and a donor programme called Number2®.
About EBX-102-02
EBX-102-02 is a next-generation, full-spectrum microbiome therapeutic composed of a high-diversity consortium of gut-derived microbes. Manufactured using the Company's proprietary AMPLA™ technology, EBX-102-02 has a robust stability profile and is formulated as an off-white, odourless powder encapsulated into oral capsules. It is designed to deliver rapid, well-tolerated, and effective symptom relief for diseases associated with gut microbiome dysfunction, including irritable bowel syndrome (IBS).
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EnteroBiotixDr James McIlroy, CEO
[email protected]
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