EBX-102 / EnteroBiotix, Imperial College London - LARVOL DELTA

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST): A Multi-Center Randomized Double-Blinded Placebo-Controlled Phase IIa Trial (ASH 2024) - "Study Design and Methods : Fifty adult patients planned to receive allogeneic HCT for hematologic malignancies will be recruited into this phase IIa trial, and randomized 1 : 1 to receive capsulized IMT (10 capsules of EBX-102-02, a next generation, full-spectrum microbiome product derived from pooled screened donor stool; EnteroBiotix Ltd) or matched placebo at 14 days prior to initiation of HCT conditioning, and followed for up to 12 months. Secondary outcomes will include tolerability, the dynamics of gut microbiome diversity metrics and taxonomy over all timepoints assessed, as well as clinical outcomes (including burden of invasive infections, days of fever, admission to intensive care, development of graft-vs-host disease (GvHD), non-relapse mortality, survival, and GvHD-free relapse-free survival). Exploratory outcomes will include the impact of IMT upon neutrophil and platelet engraftment, and T-cell immune reconstituton and repertoire, as well as exploring..."

Clinical • P2a data • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Oncology • Otorhinolaryngology • Transplantation

A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II TRIAL ASSESSING THE SAFETY AND EFFICACY OF EBX-102-02, AN ORAL FULL-SPECTRUM INTESTINAL MICROBIOTA PRODUCT, IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION; THE TRIUMPH TRIAL (DDW 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Constipation • Gastroenterology • Gastrointestinal Disorder

EnteroBiotix to Present Results from Phase 1b trial in Liver Cirrhosis at EASL Congress 2025 (GlobeNewswire) - "EnteroBiotix Limited...announced that results from its IMPuLCE Phase 1b trial evaluating EBX-102, the Company’s next-generation full-spectrum microbiome product, in patients with liver cirrhosis will be shared as an oral presentation at the European Association for the Study of the Liver (EASL) Congress 2025, taking place in Amsterdam, the Netherlands from 7-10 May 2025."

P1 data • Liver Cirrhosis

A multicentre randomised double-blind placebo-controlled phase 1b clinical trial evaluating the safety and mechanism of action of EBX-102, an oral pooled intestinal microbiota product, in liver cirrhosis: the IMPuLCE trial (EASL 2025) - " Patients with stable cirrhosis (no previous encephalopathy, not on lactulose or rifaximin and MELD <12) were recruited and randomised 2:1 active to placebo in two cohorts to receive a single dose of either 2 (Cohort 1) or 10 capsules (Cohort 2) of EBX-102 or matching placebo. EBX-102 treatment was well tolerated with an acceptable safety profile in stable cirrhosis subjects. There was a significant shift in the microbiota composition in patients who received the higher dose of EBX-102. Changes to the microbiota and their functional outputs appeared to be dose-dependent and were linked to potential clinical benefits."

Clinical • P1 data • CNS Disorders • Depression • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Liver Cirrhosis • Mood Disorders • Psychiatry • LBP

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Imperial College London | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

EnteroBiotix Announces Positive Topline Phase 2a Results with EBX-102-02, a Potential First-in-Class Treatment for Irritable Bowel Syndrome (IBS) (GlobeNewswire) - P2a | N=122 | TrIuMPH | "Patients were randomised 2:1 to receive either 8 capsules of EBX-102-02 on each of day 1 and day 7, or a matched placebo, and were followed up for 6 weeks after the first dose...Initial results from the IBS-C cohort (n=62) showed that patients receiving EBX-102-02 experienced clinically meaningful improvements across key efficacy assessments, including IBS Symptom Severity Score (IBS-SSS), stool consistency, average weekly complete bowel movements, and abdominal pain. Improvements were observed as early as week 1 and sustained through follow-up. EBX-102-02 demonstrated favourable trends over placebo across these measures, supportive of its potential therapeutic benefit for IBS-C patients...The Company expects to announce final data, inclusive of the IBS-D cohort, in Q3 2025...'we are accelerating plans to initiate a Phase 2b study later this year.'"

New P2b trial • P2a data • Inflammatory Bowel Disease