EnteroBiotix Limited has concluded patient recruitment for its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial. This trial is designed to evaluate the safety, tolerability, and efficacy of EBX-102-02 in patients suffering from irritable bowel syndrome (IBS). The study, which enrolled 122 patients across two sites in the UK, marks a significant step forward in the development of microbiome-based therapeutics for gastrointestinal disorders.
The randomized, double-blind, placebo-controlled trial included patients with confirmed severe IBS, categorized as either constipation-predominant (IBS-C) or diarrhea-predominant (IBS-D), based on Rome IV criteria. Participants were randomized in a 2:1 ratio to receive either EBX-102-02 or a placebo at two time points, one week apart, and were followed up for a six-week period.
Trial Objectives and Design
The primary objective of the TrIuMPH trial is to assess the safety and tolerability of EBX-102-02 in patients with severe IBS. Secondary objectives include evaluating the efficacy of the drug, changes in gut microbiome composition and function, and relevant biomarkers. EBX-102-02 is administered as an easy-to-take capsule, designed for stability at ambient temperature, and contains highly diverse microbial ecosystems intended to restore and fortify the microbiome.
Management Perspective
"We are grateful to the trial participants and investigators for helping us advance EBX-102-02 so expeditiously," said Dr. James McIlroy MBChB, CEO of EnteroBiotix. "Reaching this milestone ahead of schedule highlights the dedication of our clinical team and our partnership with the Functional Gut Clinic. The rapid enrolment reflects patient interest and the significant need for innovative IBS therapies that target microbiome imbalances, and we look forward to reporting topline data early next year."
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, which may include constipation, diarrhea, or both. The economic burden of IBS is substantial, with direct medical costs in the United States estimated at $10 billion annually and indirect costs as high as $20 billion (Nellesen et al. 2013).
About EBX-102-02
EBX-102-02 is EnteroBiotix’s lead drug candidate, described as a next-generation, full-spectrum microbiome therapeutic. It contains highly diverse microbial ecosystems and key functional groups that aim to improve gut health by augmenting the gut microbiome.
