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EBMT 2024 | PHOEBUS trial: oral fecal microbiotherapy for increasing OS in patients undergoing alloSCT

Florent Malard, MD, PhD, Saint-Antoine Hospital and Sorbonne University, Paris, France, introduces the PHOEBUS study (NCT05762211), a Phase IIb trial investigating the use of MaaT033, an oral pooled fecal microbiotherapy, in patients with hematological malignancies undergoing allogeneic stem cell transplantation (alloSCT). Dr Malard outlines the study design and hopes that this novel therapeutic approach will increase the overall survival (OS) of patients by preventing transplant-related complications. This interview took place at the 50th Annual Meeting of the EBMT in Glasgow, Scotland.

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Transcript (edited for clarity)

Yes of course, I am happy to discuss this Phase IIB clinical trial. So it will be a multicenter, randomized, double blind study. It will be the largest, microbiome clinical trial conducted so far, since we plan to include 387 patients, almost 400 patients. It will be conducted in Europe. So, what product are we going to use? We are going to use a MaaT033. This is some pills that are going to be given to the patients, oral pills will start before the conditioning regimen with the first seven days of treatment, three pills a day, single shot, once per day, for seven days...

Yes of course, I am happy to discuss this Phase IIB clinical trial. So it will be a multicenter, randomized, double blind study. It will be the largest, microbiome clinical trial conducted so far, since we plan to include 387 patients, almost 400 patients. It will be conducted in Europe. So, what product are we going to use? We are going to use a MaaT033. This is some pills that are going to be given to the patients, oral pills will start before the conditioning regimen with the first seven days of treatment, three pills a day, single shot, once per day, for seven days. After the patient will receive the conditioning regimen, there will be the neutropenic phase. And after neutrophil recovery around day 28 will start again to give this MaaT033, so this microbiome pills to the patients up to three months after transplant. And the primary endpoint of this clinical trial, this is the overall survival. So this is very ambitious because we plan to improve the overall survival of patients after allogeneic stem cell transplantation. So, so far, several patients have already been included and treated in France and Germany. And there is some additional country that are going to open very soon.

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Disclosures

Participation in accredited CME/CPD: IACH, Medscape Oncology, WEBMD
Consultant/strategic advisor: Therakos, Gilead, Novatis, Bristol Myers Squibb, Sanofi, AstraZeneca, MSD, Jazz Pharmaceuticals​
Patents/shares or stocks related or unrelated to this presentation: None​
Non-financial interests: SAB MaaTPharma