EnteroBiotix Limited has announced the completion of patient recruitment for its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial. The study is evaluating the safety, tolerability, and efficacy of EBX-102-02, the company’s lead asset, for the treatment of Irritable Bowel Syndrome (IBS).
The Phase 2 TrIuMPH trial is a randomized, double-blind, placebo-controlled study that enrolled 122 patients across two sites in the UK. Participants with confirmed severe IBS-C (constipation-predominant) or IBS-D (diarrhea-predominant) based on Rome IV criteria were randomized in a 2:1 ratio to receive either EBX-102-02 or a placebo. The treatments were administered at two timepoints, one week apart, with a six-week follow-up period.
The trial's primary endpoint is the assessment of the safety and tolerability of EBX-102-02 in patients with severe IBS. Secondary endpoints include evaluating efficacy, changes in gut microbiome composition and function, and relevant biomarkers.
Management Commentary
Dr. James McIlroy MBChB, CEO of EnteroBiotix, expressed gratitude to the trial participants and investigators. He highlighted that completing the recruitment ahead of schedule underscores the dedication of the clinical team and their partnership with the Functional Gut Clinic. He also noted that the rapid enrollment reflects patient interest and the significant need for innovative IBS therapies that target microbiome imbalances. Topline data is expected early next year.
About EBX-102-02
EBX-102-02 is described as a next-generation, full-spectrum drug candidate. It contains highly diverse microbial ecosystems and key functional groups designed to restore and fortify the gut microbiome. The drug is formulated as an easy-to-take capsule and has demonstrated stability at ambient temperature.
Irritable Bowel Syndrome (IBS)
IBS is a chronic relapsing functional gastrointestinal disorder affecting approximately 1 in 8 people. Patients experience a range of symptoms, including chronic abdominal pain, cramping, bloating, and changes in bowel movements, such as constipation (IBS-C) or diarrhea (IBS-D). In the United States, the direct medical costs associated with IBS are estimated to be as high as $10 billion annually, with indirect costs reaching $20 billion (Nellesen et al. 2013).
