12 November 2020 - - France-based MaaT Pharma has treated its first patient in a Phase 1 clinical trial to evaluate the safety and tolerability of MaaT033, a capsule formulation of the company's lead biotherapeutic, MaaT013, characterized by high microbial species diversity and richness, the company said.

The trial named CIMON will enroll patients with acute myeloid leukemia or high-risk Myelodysplastic Syndrome following intensive chemotherapy.

MaaT033 is being developed to provide a complete approach to restoring a functional gut microbiome and re-establishing immune system homeostasis to treat life-threatening diseases.

The capsule formulation provides a convenient route of administration for patients who are already undergoing intensive treatment regimens, while providing a high and consistent richness of microbial species, derived from pooling the intestinal ecosystems of healthy donors.

The CIMON trial (NCT04150393) will enroll 27 patients in 4 centers. It is an open-label Phase 1b study to investigate the maximum tolerated dose of MaaT033, over seven or 14 days, that supports gut microbiome engraftment in patients with AML or high-risk MDS that are undergoing intensive chemotherapy.

Overall safety, tolerability, and dose regimen will be evaluated, as will the impact on the gut microbiome, to identify a recommended Phase II dose.

The CIMON Phase 1b trial is expected to be completed in the fourth quarter 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 in order to improve clinical outcomes as well as control adverse events related to conventional treatments for cancer.

The capsule formulation eases administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory "Butycore" species, which characterize MaaT Pharma's products.

MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.