MaaT Pharma's MaaT033 For Allo-HSCT Patients Clears Second DSMB Safety Review In Phase 2b Trial

(RTTNews) - MaaT Pharma (MAAT.PA), a clinical-stage biotech company pioneering Microbiome Ecosystem Therapies (MET) for cancer patients, announced a positive outcome from the second pre-planned safety interim analysis of its Phase 2b PHOEBUS trial. The trial is evaluating the safety and efficacy of MaaT033 in patients undergoing Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT).

The independent Data Safety Monitoring Board (DSMB) conducted an unblinded review of safety data from the first 120 enrolled patients, including 60 who received MaaT033. The DSMB identified no safety concerns or excessive mortality related to MaaT033 and recommended that the trial continue as planned. This marks a key milestone in the development of MaaT033, which continues to demonstrate a favorable safety and tolerability profile.

The PHOEBUS trial is the largest randomized controlled study of microbiome therapy in oncology to date. It includes a built-in safety protocol to monitor non-relapse mortality, particularly during the vulnerable post-transplant period. In addition to this interim review, routine safety assessments are conducted every six months. All evaluations to date have supported the continued progression of the trial without modifications.

Enrollment for the PHOEBUS trial is ongoing across 60 clinical sites in France, Germany, Belgium, Spain, the Netherlands, and the United Kingdom, with a target of 387 patients. The next routine DSMB safety review is scheduled for the first quarter of 2026. MaaT Pharma remains committed to advancing MaaT033 as a potential therapeutic option for patients with blood cancers undergoing allo-HSCT.

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