EnteroBiotix has announced the completion of enrolment in the Phase IIa MAST trial of EBX-102-02 in patients who are undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) for haematological malignancies.
The randomised, multi-centre, placebo-controlled, double-blind trial enrolled 50 patients, who will receive either EBX-102-02 or a matched placebo before conditioning chemotherapy. They are followed for 12 months after transplantation. It is conducted across multiple centres.
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The primary endpoint is the change in gut microbiota alpha diversity from baseline to post-transplant timepoints. Secondary and exploratory endpoints cover clinical transplant outcomes, tolerability, safety, and translational microbiome and immune analyses.
Imperial College London is sponsoring the study, which is being funded by the Medical Research Council. The trial’s co-chief investigators are Professor Julian Marchesi and Dr Jiri Pavlu, supported by haematologists from leading UK transplant centres. EnteroBiotix is providing EBX-102-02 for the study.
The MAST trial will investigate if a single pre-emptive oral dose of EBX-102-02 can enhance or preserve microbial diversity during transplantation. Topline results are anticipated in the first half of 2027.
MAST extends EnteroBiotix’s broader clinical programme, following earlier positive Phase IIa data in irritable bowel syndrome and Phase Ib outcomes in liver cirrhosis.
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By GlobalDataIt underpins the company’s initiative to develop full-spectrum microbiome therapeutics for significant disease areas with a strong biological rationale.
EnteroBiotix CEO Dr James McIlroy 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 top line data in H1 2027.”
