EnteroBiotix has announced the completion of patient recruitment for its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial, designed to assess the safety, tolerability, and efficacy of EBX-102-02 in patients suffering from Irritable Bowel Syndrome (IBS). The randomized, double-blind, placebo-controlled study enrolled 122 patients across two sites in the UK, marking a significant step forward in the development of microbiome-based therapeutics for this prevalent gastrointestinal disorder.
Trial Design and Patient Population
The TrIuMPH trial enrolled patients diagnosed with severe IBS-C or IBS-D according to the Rome IV criteria. Participants were randomized in a 2:1 ratio to receive either EBX-102-02 or a placebo, administered at two timepoints one week apart, followed by a six-week observation period. Specifically, the trial included 62 participants with IBS-C and 60 participants with IBS-D, reflecting the clinical diversity of the condition.
Objectives and Endpoints
The primary objective of the Phase 2 trial is to evaluate the safety and tolerability of EBX-102-02 in patients with severe IBS. Secondary objectives include assessing the efficacy of the drug, changes in gut microbiome composition and function, and relevant biomarkers. These endpoints will provide a comprehensive understanding of the drug's impact on both patient symptoms and the underlying microbiome.
EBX-102-02: A Novel Microbiome Therapeutic
EBX-102-02 is described as a next-generation, full-spectrum drug candidate containing highly diverse microbial ecosystems and key functional groups designed to restore and fortify the gut microbiome. It is administered as an easy-to-take capsule, demonstrating stability at ambient temperature, which could offer significant advantages in terms of storage and administration.
The Need for New IBS Therapies
Irritable bowel syndrome (IBS) is a chronic relapsing functional gastrointestinal disorder affecting an estimated 1 in 8 people, characterized by symptoms such as chronic abdominal pain, cramping, bloating, and changes in bowel movements. The economic burden of IBS is substantial, with direct medical costs in the United States estimated at $10 billion annually and indirect costs reaching $20 billion. Current treatments often provide limited relief, highlighting the urgent need for innovative therapies that target the underlying causes of IBS, such as microbiome imbalances.
Management Perspective
Dr. James McIlroy MBChB, CEO of EnteroBiotix, expressed gratitude to the trial participants and investigators, emphasizing the rapid enrollment as a reflection of patient interest and the significant need for innovative IBS therapies. He stated, "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."
Anticipated Topline Data
EnteroBiotix anticipates releasing topline data from the TrIuMPH trial in the first quarter of 2025. These results will be crucial in determining the future development path of EBX-102-02 and its potential to address the unmet needs of patients with irritable bowel syndrome.
