MaaT Pharma, a clinical-stage biotechnology company focused on developing Microbiome Ecosystem Therapies in oncology, today announced that the Data Safety and Monitoring Board (DSMB) recommended to proceed to the fourth cohort of the dose-finding Phase 1b CIMON clinical trial, without modifications. The DSMB is an independent committee monitoring the progress of the company’s clinical trial and is reviewing safety, tolerability and data quality while the trial is ongoing.
“We are very pleased that the third of five cohorts in this important study with MaaT033 has successfully been completed without any safety signals reported. This is a very meaningful step towards determining the target dose of this oral capsule product candidate, and we expect to initiate a pivotal Phase 3 study next year,”
commented John Weinberg, MD, Chief Medical Officer at MaaT Pharma.
The CIMON trial (NCT04150393) is enrolling a total of 27 patients at 6 sites across France. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy.
The CIMON Phase 1b trial is expected to be completed at the end of 2021.
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness microbiome biotherapeutic. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory “Butycore” species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.