EnteroBiotix doses first patient in Phase 2b RISE Study of EBX-102-02 in IBS with constipation

EnteroBiotix Limited, a clinical-stage biopharmaceutical company developing orally delivered full-spectrum microbiome therapeutics for gastrointestinal disease, today announced that the first patient has been dosed in RISE, its Phase 2b clinical trial evaluating EBX-102-02 in moderate-to-severe irritable bowel syndrome with constipation (IBS-C), marking an important milestone in the Company’s clinical development programme.

EBX-102-02 is EnteroBiotix’s lead next-generation, orally delivered, full-spectrum investigational microbiome therapeutic, designed to restore gut microbial ecosystem function, an underlying driver of IBS-C. IBS-C is a chronic condition that affects millions of people worldwide, with many patients continuing to experience persistent symptoms despite currently available therapies. The RISE study, which stands for Restoring Intestinal Symbiosis for Efficacy in IBS, builds on the positive clinical signals observed in the Company’s Phase 2a TrIuMPH study and supports the continued development of EBX-102-02 as a potential first-in-class therapy for IBS. 

RISE (ISRCTN15681288) is a randomised, double-blind, placebo-controlled, interventional Phase 2b trial expected to enrol approximately 300 patients with moderate-to-severe IBS-C across seven sites in the United Kingdom. The study will evaluate the efficacy, safety and tolerability of EBX-102-02, with endpoints assessing clinically relevant IBS-C outcomes including abdominal pain, bowel habit parameters and IBS-specific quality of life. Exploratory analyses will also be conducted to further characterise microbial engraftment following EBX-102-02 administration, the utility of methane breath testing and potential mechanism of action.

Today’s milestone follows positive results from the Company’s Phase 2a TrIuMPH study, which evaluated EBX-102-02 in patients with IBS-C and IBS-D. In TrIuMPH, EBX-102-02 demonstrated clinically meaningful improvements across key symptom domains, including IBS symptom severity, abdominal pain, bowel habit parameters and quality of life, together with evidence of enhanced microbiome diversity.

Mr Paul Goldsmith MD, FRCS, Consultant General Surgeon at Manchester University NHS Foundation Trust and Chief Investigator of the RISE study, said: “IBS-C can be a highly burdensome condition, with many patients continuing to experience abdominal pain, bloating and constipation despite available treatment options. EBX-102-02 represents a novel investigational approach that is designed to modulate the gut microbial ecosystem, which is increasingly recognised as an important area of interest in IBS. The RISE study builds on encouraging Phase 2a clinical signals and will help evaluate whether this approach can deliver meaningful benefit for patients living with IBS-C.”

Professor Yan Yiannakou, Consultant Neurogastroenterologist at County Durham and Darlington NHS Foundation Trust, said:

There is growing evidence that disruption of the gut microbiome plays an important role in the pathophysiology of IBS-C. While existing therapies can improve symptoms for some patients, many continue to experience a substantial burden of disease and remain dissatisfied with available treatment options. EBX-102-02 represents a fundamentally different therapeutic approach, seeking to address dysfunction in the gut microbial ecosystem rather than only stimulate bowel activity. The RISE study is therefore an important clinical trial, and its results will be of considerable interest to clinicians and patients.

Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said:

Dosing the first patient in RISE is an important step towards evaluating the potential of EBX-102-02 to address the underlying biology of IBS-C. The trial reflects our commitment to building a leading position in full-spectrum microbiome therapeutics for high-burden gastrointestinal diseases. We are grateful to the patients, investigators and clinical teams supporting the study and look forward to advancing this important programme.