On July 2, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that the DSMB completed its first safety assessment of the Phase 2b trial PHOEBUS, the largest one to date for a microbiome therapy in oncology, and recommended continuation of the trial without modification (Press release, MaaT Pharma, JUL 2, 2024, View Source [SID1234644651]). The trial is an international, multi-center, randomized, double-blind, testing MaaT033, an oral freeze-dried formulation against placebo, set to be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients (NCT05762211).

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The DSMB, composed of 5 independent experts, reviewed safety data on the first 20 patients (cutoff date as of April 30th, 2024) and concluded that safety was acceptable and well tolerated. Since its first clinical entry in 2020, MaaT033, a drug candidate produced by combining the microbiota from multiple donors using a patented "pooling" process, has continuously displayed a good safety profile.

"The positive outcome of this first DSMB review of the PHOEBUS study significantly builds on the favorable safety and tolerability profile exhibited by MaaT033," said Gianfranco Pittari, M.D., PhD, Chief Medical Officer of MaaT Pharma. "We are very enthusiastic about MaaT033’s potential to ensure an optimal microbiome ecosystem and enhance clinical outcomes in patients undergoing allogeneic stem cell transplantation."

"MaaT033 is designed for ambulatory use and chronic treatment; it will address a substantial market of approximately 11,000 patients annually, and with its freeze-dried capsule formulation it will significantly drive our growth," highlighted Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "With the GMP manufacturing facility at full capacity, we will produce up to 1,300,000 capsules annually, meeting patient demand and supporting our innovative microbiome therapies".