EnteroBiotix announces completion of enrolment in Phase 2a trial evaluating EBX-102-02 prior to Allogeneic Stem Cell Transplantation
EnteroBiotix, a clinical-stage biopharmaceutical company developing best-in-class microbiome therapies, today announced that the investigator-initiated Phase 2a MAST trial (Intestinal Microbiota Transplant prior to Allogeneic Stem Cell Transplantation) has completed its enrolment of 50 adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) for defined haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to conditioning chemotherapy and are followed for 12 months post-transplant.
The study is sponsored by Imperial College London and funded by the Medical Research Council (MRC). It is led by Co-Chief Investigators Professor Julian Marchesi and Dr Jiri Pavlu, together with haematologists across leading UK transplant centres. EnteroBiotix is supplying EBX-102-02 for use in the trial.
Profound disruption of the gut microbiome is common during allo-HSCT, and loss of microbial diversity has been associated with increased risk of infection, graft-versus-host disease (GVHD) and reduced overall survival. The MAST trial will assess whether a single dose of pre-emptive orally administered EBX-102-02 can enhance and preserve microbial diversity during the transplantation period. Exploratory outcomes evaluate clinical transplant outcomes. Topline data are expected in H1 2027.
MAST builds on EnteroBiotix’s broader clinical programme, following previously announced positive Phase 2a data in irritable bowel syndrome (IBS) and Phase 1b data in liver cirrhosis, and supports the Company’s strategy to develop full-spectrum microbiome therapeutics across major disease areas supported by a strong biological rationale.
Professor Julian Marchesi said:
Profound disruption of the intestinal microbiome is common during allogeneic stem cell transplantation and has been strongly associated with adverse outcomes. MAST builds on prior promising work from the Imperial team utilising traditional FMT approaches and has been designed to assess whether pre-emptive microbiota restoration using EBX-102-02 can preserve microbiome diversity during the transplant period and potentially improve post-transplant outcomes. We are pleased to have completed enrolment and thank the patients and clinical teams involved.
Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said:
Completion of enrolment in MAST builds on our recent progress in IBS and cirrhosis and marks another step in evaluating the potential of EBX-102-02 across multiple indications with high unmet medical need. We are excited about the potential of our platform and technology for supporting the treatment of oncology patients. We thank the Imperial investigators for their collaboration and look forward to topline data in H1 2027.