MaaT Pharma has reported positive data from Phase Ib CIMON clinical trial of MaaT033 in acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome (HRMS) patients who received intensive chemotherapy.

MaaT033 is an oral, full-ecosystem, off-the-shelf, pooled-donor, high-richness microbiome ecosystem therapy (MET).

It is intended to restore the gut ecosystem to full functionality to boost clinical outcomes and control adverse events linked to traditional liquid tumour therapies. 

The open-label, dose-ranging trial analysed the safety and tolerability of MaaT033 in AML or HRMS patients.

It enrolled 21 subjects in four dose-escalation arms across six trial centres in France. 

The maximum tolerated dose of MaaT033 in trial subjects was also analysed as part of the trial.

According to trial findings from the immuno-compromised patient population, MaaT033 demonstrated to have good safety and tolerability profile, assessed as the primary endpoint. 

Furthermore, the topline data also showed MaaT033’s quick and persistent engraftment in the gut of patients. 

The trial also aided in selecting the recommended dose for MaaT033, which is currently confidential. 

The results support the company’s plans to commence a Phase II/III trial later this year to analyse the ability of MaaT033 to boost survival and avoid complications in blood cancer patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

MaaT Pharma CEO and co-founder Hervé Affagard said: “Parallel to the clinical successes of our lead candidate MaaT013, we developed MaaT033 as our first oral formulation, and the strength of the engraftment we have seen in these cohorts exceeds our expectations. 

“Together with a good safety profile, this solid evidence for our first oral candidate is a crucial milestone for MaaT Pharma.”

In January this year, the company reported positive interim engraftment data from the first four groups of the Phase Ib CIMON trial of MaaT033 for oral dosing.