EnteroBiotix Completes Phase 2 Study Recruitment of EBX-102-02 IBS

EnteroBiotix Limited recently announced the completion of recruitment in its Phase 2 TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) trial assessing the safety, tolerability and efficacy of EBX-102-02, the company’s lead asset, for the treatment of patients with Irritable Bowel Syndrome (IBS).

The randomized, double-blind, placebo-controlled Phase 2 TrIuMPH trial enrolled a total of 122 patients at two sites in the UK. Patients with confirmed severe IBS-C or IBS-D using Rome IV criteria were randomized 2:1 to receive EBX-102-02 or placebo at two timepoints one week apart and were followed up over a six-week period.

The study’s primary objective is to evaluate the safety and tolerability of EBX-102-02 in patients with severe IBS. Secondary objectives included assessing efficacy, changes in gut microbiome composition and function and relevant biomarkers.

Dr. James McIlroy MBChB, CEO of EnteroBiotix, said “We are grateful to the trial participants and investigators for helping us advance EBX-102-02 so expeditiously. 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.”

EnteroBiotix is a clinical-stage biotechnology company developing therapeutics to treat gastrointestinal and hepatic diseases. EnteroBiotix’s therapies contain highly diverse ecosystems of microorganisms stabilized using proprietary platform technology and designed to improve gut health by augmenting the gut microbiome. EnteroBiotix has completed enrolment of patients in a Phase 2 double-blind, placebo-controlled, multi-centre clinical study in irritable bowel syndrome (IBS) and is progressing a Phase 2a study with Imperial College in patients undergoing allo-HSCT. The company recently announced positive results in a Phase 1b clinical study of its full-spectrum product EBX-102 in patients with liver cirrhosis, demonstrating proof-of-principle across multiple microbiome assessments, inflammatory biomarkers and clinical assessments, supporting its continued development as the first microbial therapy for individuals with liver disease.

EBX-102-02 is a next-generation, full-spectrum drug candidate that contains highly diverse microbial ecosystems and key functional groups that restore and fortify the microbiome. The drug is presented as an easy to take capsule with demonstrated stability at ambient temperature.

TrIuMPH (Treating IBS with an Intestinal Microbiota Product for Health) is a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate the safety and tolerability of EBX-102-02, EnteroBiotix’s next-generation, full-spectrum microbiome drug candidate, in patients with irritable bowel syndrome (IBS).

A total of 122 participants with IBS were recruited to TrIuMPH at two sites. 62 participants with constipation predominant IBS (IBS-C) and 60 participants with diarrhea predominant IBS (IBS-D) were dosed with EBX-102-02 or matching placebo and followed up for six weeks.

Irritable bowel syndrome (IBS) is a chronic relapsing functional gastrointestinal (GI) disorder, with patients experiencing a range of symptoms, such as chronic abdominal pain, cramping, bloating and change in bowel movements – which may include constipation, diarrhoea, or both. It is estimated that up to 1 in 8 people suffer from IBS type symptoms, and there is approximately an equal split between patients experiencing predominantly constipation (IBS-C) versus diarrhoea (IBS-D) pattern. In the United States, direct medical costs associated with IBS are estimated to be as high as $10b annually, with indirect costs as high as $20b (Nellesen et al. 2013).

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.