EnteroBiotix has announced positive topline results from its Phase 2a TrIuMPH clinical trial evaluating EBX-102-02, a next-generation full-spectrum microbiome product, in patients with irritable bowel syndrome with constipation (IBS-C). The data suggest the therapy could represent a potential first-in-class treatment addressing the underlying biology of this challenging gastrointestinal disorder.
The multicentre, randomized, double-blind, placebo-controlled study enrolled 122 patients with moderate to severe IBS-C and IBS with diarrhea (IBS-D). Participants were randomized 2:1 to receive either EBX-102-02 (8 capsules on days 1 and 7) or matched placebo, with a 6-week follow-up period.
Significant Clinical Improvements in IBS-C Patients
Initial results from the 62-patient IBS-C cohort demonstrated clinically meaningful improvements across key efficacy measures compared to placebo. Patients receiving EBX-102-02 showed notable benefits in:
- IBS Symptom Severity Score (IBS-SSS)
- Stool consistency
- Average weekly complete bowel movements
- Abdominal pain
These improvements were observed as early as week 1 and maintained throughout the follow-up period, suggesting durable therapeutic effects.
"IBS remains one of the most challenging gastrointestinal disorders to manage, with limited effective treatment options that address the underlying disease biology," said Mr. Paul Goldsmith MD, FRCS, Consultant General Surgeon at the University of Manchester NHS Trust and Chief Investigator of the TrIuMPH study. "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."
Safety Profile and Microbiome Impact
The treatment was well-tolerated, with adverse events primarily characterized as mild, self-limiting, and gastrointestinal in nature. Importantly, no severe diarrhea was reported, and no serious adverse events were observed during the study.
Shotgun metagenomic sequencing revealed significant shifts in intestinal microbiota composition among patients receiving EBX-102-02. The intestinal microbiota of treated patients became more similar to the composition of EBX-102-02 itself, with these changes persisting throughout the follow-up period. This provides mechanistic evidence supporting the therapeutic approach of microbiome modulation for IBS.
Addressing a Significant Unmet Need
IBS affects approximately 10-15% of the global population and is characterized by chronic abdominal pain, bloating, and altered bowel habits. Current treatment options often provide inadequate symptom relief and rarely address the underlying pathophysiology of the condition.
Professor Yan Yiannakou, Consultant Neurogastroenterologist at County Durham and Darlington NHS Foundation Trust, expressed enthusiasm about the findings: "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."
Development Plans and Future Directions
EnteroBiotix expects to announce final data, including results from the IBS-D cohort, in Q3 2025. Based on these promising initial findings, the company is accelerating plans to initiate a larger Phase 2b study later this year.
"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."
This positive development in IBS builds upon favorable results from a Phase 1b study in liver cirrhosis announced by the company in November 2024, suggesting broader potential applications for EnteroBiotix's microbiome-based therapeutic platform.
About EBX-102-02
EBX-102-02 is a next-generation full-spectrum microbiome product containing a high-diversity microbiome consortium, stabilized within a dried, off-white odorless powder. The therapy is designed to provide rapid, well-tolerated, and effective treatment for symptoms of diseases linked to gut microbiome dysfunction, including IBS.
The product represents a novel approach to IBS treatment by directly addressing potential microbial imbalances that may contribute to disease pathophysiology, rather than merely targeting individual symptoms. This mechanism of action differentiates it from conventional IBS therapies currently on the market.
Microbiome Therapeutics: An Emerging Treatment Paradigm
The human gut microbiome comprises trillions of microorganisms that play crucial roles in digestion, immune function, and overall health. Disruptions in the microbiome composition and function have been implicated in various gastrointestinal disorders, including IBS.
Microbiome-based therapeutics represent an emerging treatment paradigm that aims to restore beneficial microbial communities and functions. Unlike traditional pharmaceuticals that target specific molecular pathways, these therapies seek to reestablish a healthy microbial ecosystem that can address multiple aspects of disease pathophysiology simultaneously.
EnteroBiotix's approach with EBX-102-02 exemplifies this paradigm, offering a potential new direction for IBS treatment that could address fundamental aspects of the condition rather than merely managing symptoms.
