EnteroBiotix Reports Positive Phase 2a Trial Results for EBX-102-02 in IBS-C

EnteroBiotix Limited, a clinical-stage biopharmaceutical company focussed on developing best-in-class drugs for gut health, today announced positive initial results with EBX-102-02, the company’s next-generation full-spectrum microbiome product, from the TrIuMPH phase 2a clinical trial in adults with irritable bowel syndrome with constipation (IBS-C).

The multicentre, randomised, double-blind, placebo-controlled TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) study assessed the safety, tolerability, and preliminary efficacy of EBX-102-02 in 122 patients with moderate to severe IBS-C and IBS with diarrhoea (IBS-D). Patients were randomised 2:1 to receive either 8 capsules of EBX-102-02 on each of day 1 and day 7, or a matched placebo, and were followed up for 6 weeks after the first dose.

Initial results from the IBS-C cohort (n=62) showed that patients receiving EBX-102-02 experienced clinically meaningful improvements across key efficacy assessments, including IBS Symptom Severity Score (IBS-SSS), stool consistency, average weekly complete bowel movements, and abdominal pain. Improvements were observed as early as week 1 and sustained through follow-up. EBX-102-02 demonstrated favourable trends over placebo across these measures, supportive of its potential therapeutic benefit for IBS-C patients.

EBX-102-02 was well-tolerated, with adverse events being mainly mild, self-limiting, and gastrointestinal in nature. No severe diarrhoea was reported, and no serious adverse events were observed. Shotgun metagenomic sequencing revealed a significant shift in the intestinal microbiota composition in patients who received EBX-102-02. Their intestinal microbiota composition became more similar to the composition of EBX-102-02, and this similarity persisted during follow-up.

The company expects to announce final data, inclusive of the IBS-D cohort, in Q3 2025. EnteroBiotix is continuing engagement with regulatory authorities to agree the next steps in its clinical development programme for EBX-102-02 in IBS. Based on these promising results, the company plans to proceed with a larger phase 2b trial to confirm efficacy.

Paul Goldsmith MD, FRCS, consultant general surgeon at the University of Manchester NHS Trust and Chief Investigator of the TrIuMPH study, commented: “IBS remains one of the most challenging gastrointestinal disorders to manage, with limited effective treatment options that address the underlying disease biology. The positive topline results from this phase 2a study show that EBX-102-02 could be a well-tolerated, first-in-class therapy with the potential to address this critical unmet medical need.”

Professor Yan Yiannakou, consultant neurogastroenterologist at County Durham and Darlington NHS Foundation Trust, said: “I am excited by these phase 2a data for EBX-102-02, which provide encouraging initial evidence that microbiome modulation through a full-spectrum drug is a viable therapeutic approach for IBS. The clinically meaningful improvements in IBS symptom severity, stool consistency and abdominal pain observed in this trial are extremely promising. There is a clear and urgent need for innovation in this space, and I look forward to supporting the continued development of this promising therapy, which could be transformational for IBS patients.”

“These topline results show that our full-spectrum microbiome-based drug is a potential breakthrough for IBS treatment,” said Dr. James McIlroy MBChB, CEO of EnteroBiotix. “The data support our approach and bring us closer to delivering a much-needed solution for patients with limited options. We are grateful to the study participants and our partners at the Functional Gut Clinic for their participation in the trial. Building on this progress, we are accelerating plans to initiate a phase 2b study later this year.”

This positive news in IBS builds upon the positive results from a phase 1b study in liver cirrhosis announced in November 2024.

EBX-102-02 is a next-generation full-spectrum microbiome product that contains a high-diversity microbiome consortium, stabilised within a dried, off-white odourless powder. EBX-102-02 is designed to provide rapid, well-tolerated, and effective treatment for the symptoms of diseases linked to the gut microbiome, including IBS.  

The Functional Gut Clinic (FGC) is the UK’s leading independent provider of gastrointestinal physiology testing and diagnostics. FGC provides both private and NHS services around the UK and is the only independent GI physiology clinic to have Improving Quality in Physiological Services (IQIPS)/United Kingdom Accreditation Services (UKAS) and Care Quality Commission (CQC) accreditation. Established in 2013, FGC has an extensive R&D and Clinical trials portfolio helping to design and test future digestive health tests and treatments.

EnteroBiotix is a clinical-stage biotechnology company developing microbiome-based therapeutics for gastrointestinal and hepatic diseases.

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