MaaT Pharma has announced positive interim engraftment results from the first four groups of the Phase Ib CIMON clinical trial of its microbiome ecosystem therapy, MaaT033, for oral dosing. 

The positive results could aid in advancing MaaT033 to a Phase II/III trial, which could commence in the second half of this year. Full results from the Phase Ib CIMON trial are estimated to be available in the first half of this year.

The open-label, dose-ranging trial had 21 subjects across six study centres in France and were enrolled into four cohorts to receive three capsules of MaaT033 daily for 14 days.

It analysed MaaT033’s maximum tolerated dose over seven or 14 days of treatment that aids ideal gut microbiome colonisation in acute myeloid leukaemia or high-risk myelodysplastic syndrome patients who received intensive chemotherapy. 

Results from four out of five intended groups of the dose-ranging trial demonstrated suitable safety as well as good microbiome engraftment. This was characterised by the microbial operational taxonomic unit’s (OTU) presence in the gut due to treatment, not observed during initiation of therapy.

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The latest trial findings indicate the first validation of MaaT033’s mechanism of action in humans. A full-ecosystem, pooled-donor therapy, MaaT033 can potentially restore the gut ecosystem to full functionality to improve clinical outcomes. It can also aid in controlling adverse events linked to standard liquid tumour treatments. 

The treatment is intended to boost survival in hemato-oncology patients who are receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). 

MaaT033’s capsule form makes administration easier while upholding the diversity of microbial species, including anti-inflammatory But core species that distinguish microbiome ecosystem therapies of MaaT Pharma.

MaaT Pharma CEO and co-founder said Hervé Affagard said: “These interim results are an important milestone for MaaT Pharma as MaaT033 is our second product, and our first oral formulation, to demonstrate proof of engraftment in humans. 

“This expands the potential of our proprietary Microbiome Ecosystem Therapy (MET) platform to the ambulatory setting, after positive data achieved in aGvHD with MaaT013, an enema product for acute, hospital use.”

In October 2018, the company dosed the first subject in a Phase II trial of MaaT013 to treat steroid-resistant acute SR-aGvHD.