In This Article:
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The Independent Data Safety and Monitoring Board (DSMB) has recommended that the trial proceeds as planned without modification.
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Consistent good safety profile and tolerability for MaaT033, a pooled donor-derived drug candidate in oral formulation.
LYON, France, January 21, 2025--(BUSINESS WIRE)--Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that the DSMB completed its second safety assessment of the Phase 2b trial PHOEBUS, the largest randomized controlled trial assessing microbiome therapy in oncology to date, and recommended continuation of the trial without modification. The routine DSMB, which convenes every six months, is composed of 5 independent experts, reviewed safety data on 59 patients (cutoff date as of October 31st, 2024) and concluded that MaaT033 is well tolerated and has an acceptable safety profile.
"We are pleased to see that the safety profile of MaaT033 remains positive, and the trial is advancing as planned. Additionally, we are proud to report that recruitment for our Phase 2b trial is progressing well, with 80 patients enrolled as of end of December 2024", said Gianfranco Pittari, MD, PhD, Chief Medical Officer of MaaT Pharma.
Patient enrollment continues to progress at a steady pace in France, Germany, Belgium, Spain, Netherlands and the United Kingdom, with 54 clinical centers open to date. The Phoebus trial is an international, multi-center, randomized, double-blinded study, testing MaaT033, an oral freeze-dried multi-donor formulation, as a potential adjunctive treatment for patients receiving Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT), against placebo. The trial is expected to enroll 387 patients and is set to be conducted in up to 56 clinical investigation sites (NCT05762211).
Upcoming milestones include the routine DSMB review for ongoing safety, conducted every six months, as well as a DSMB assessing mortality imbalance between arms, respectively at 60 patients (expected in Q1 2025) and at 120 patients (expected in Q3 2025), after 90 days of follow-up post Allo-HSCT.
Previous data from a Phase 1b trial in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) having received intensive chemotherapy (reported in January 2022) and from a Phase 1 trial in patients with Amyotrophic Lateral Sclerosis (ALS) (reported in February 2024) further support MaaT033's favorable safety and tolerability profile.