EnteroBiotix Doses First Patient in Phase 2b RISE Trial of EBX-102-02 for IBS-C

EnteroBiotix Reaches a New Clinical Milestone

EnteroBiotix Limited has announced that the first patient has been dosed in its Phase 2b RISE clinical trial evaluating EBX-102-02 for moderate-to-severe irritable bowel syndrome with constipation (IBS-C).

The milestone marks another step forward in the company's clinical development program as it continues to develop microbiome-based treatments for gastrointestinal diseases.

The RISE study is designed to evaluate whether EBX-102-02 can help patients by restoring the balance of bacteria in the gut, which is believed to play an important role in IBS-C.

What Is EBX-102-02?

EBX-102-02 is EnteroBiotix's lead investigational microbiome therapy.

Unlike traditional IBS-C treatments that mainly focus on relieving symptoms, EBX-102-02 is designed to restore the gut microbial ecosystem. The company believes this approach targets one of the underlying biological causes of the disease rather than simply managing constipation or abdominal discomfort.

The therapy is delivered orally and is manufactured using the company's proprietary processing technology to provide a stable, full-spectrum microbiome product.

At present, EBX-102-02 remains an investigational treatment and has not been approved for clinical use outside regulated clinical trials.

RISE Study Will Enroll Around 300 Patients

The RISE study, which stands for Restoring Intestinal Symbiosis for Efficacy in IBS, is a randomized, double-blind, placebo-controlled Phase 2b clinical trial.

Researchers plan to enroll approximately 300 patients with moderate-to-severe IBS-C across seven clinical sites in the United Kingdom.

The study will evaluate the efficacy, safety, and tolerability of two formulations of EBX-102-02.

Researchers will assess important treatment outcomes, including abdominal pain, bowel movement patterns, constipation symptoms, and improvements in IBS-related quality of life.

The trial will also include exploratory analyses to better understand how the treatment changes the gut microbiome, evaluate microbial engraftment after treatment, study methane breath testing, and investigate the therapy's possible mechanism of action.

Study Builds on Positive Phase 2a Results

The RISE trial follows encouraging findings from EnteroBiotix's earlier Phase 2a TrIuMPH study.

In that study, EBX-102-02 was evaluated in patients with both constipation-predominant IBS (IBS-C) and diarrhea-predominant IBS (IBS-D).

According to the company, patients treated with EBX-102-02 experienced clinically meaningful improvements across several important measures, including overall IBS symptom severity, abdominal pain, bowel habits, and quality of life.

The study also showed evidence of increased diversity in the gut microbiome following treatment.

Researchers Highlight the Need for Better IBS-C Treatments

Paul Goldsmith, MD, FRCS, Consultant General Surgeon at Manchester University NHS Foundation Trust and Chief Investigator of the RISE study, said IBS-C continues to place a significant burden on many patients.

He explained that abdominal pain, bloating, and constipation often continue even after existing treatments have been used. He added that EBX-102-02 offers a different approach by targeting the gut microbial ecosystem, which is becoming an increasingly important area of research in IBS.

According to him, the RISE study will help determine whether this strategy can provide meaningful benefits for patients.

Experts See Growing Interest in Microbiome-Based Therapies

Professor Yan Yiannakou, Consultant Neurogastroenterologist at County Durham and Darlington NHS Foundation Trust, said there is increasing scientific evidence linking disruption of the gut microbiome to the development of IBS-C.

He noted that while current therapies can help some patients, many people continue to experience ongoing symptoms and remain dissatisfied with available treatment options.

He said EBX-102-02 differs from existing therapies because it aims to restore gut microbial function instead of simply stimulating bowel activity, making the RISE study an important clinical investigation for both physicians and patients.

Company Continues to Advance Its Microbiome Platform

Dr. James McIlroy, Chief Executive Officer of EnteroBiotix, said dosing the first patient in the RISE study represents an important milestone in evaluating the potential of EBX-102-02 to address the underlying biology of IBS-C.

He added that the study reflects the company's commitment to developing full-spectrum microbiome therapies for gastrointestinal diseases with significant unmet medical needs.

He also thanked the patients, investigators, and clinical teams participating in the study as the program moves forward.

IBS-C Remains a Significant Unmet Medical Need

Irritable bowel syndrome with constipation is a chronic disorder involving communication between the gut and the brain.

People living with IBS-C commonly experience abdominal pain, bloating, constipation, and reduced quality of life. Although several treatments are currently available, many patients continue to struggle with persistent symptoms.

EnteroBiotix believes therapies that restore the gut microbiome could offer a new treatment approach by addressing the biological factors that contribute to the disease rather than focusing only on symptom relief.

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