On June 2, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported completion of its Phase 1b CIMON trial evaluating the safety and tolerability of MaaT033, the Company’s high-richness, high-diversity MET for oral administration, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HRMS) having received intensive chemotherapy (Press release, MaaT Pharma, JUN 2, 2022, View Source [SID1234615420]). In this study, performed in an immuno-compromised patient population, MaaT033 presented a good safety and tolerability profile, evaluated as the primary endpoint. The topline results also show rapid and persistent engraftment of MaaT033 in the patients’ gut. The study data support the Company’s preparation to initiate a Phase 2/3 trial later this year to evaluate MaaT033’s ability to improve survival and prevent complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with blood cancers. Every year, approximately 22,000 patients require allo-HSCT in the seven major markets. MaaT033’s oral formulation is designed to support long-term, ambulatory use, opening up new potential development opportunities for the Company. Today’s announcement confirms previously-announced promising interim results of the trial, which allowed early completion of the study.
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"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 candiate is a crucial milestone for MaaT Pharma," commented Hervé Affagard, CEO and co-founder of MaaT Pharma. "Allo-HSCT is a curative treatment of liquid tumors, that is unfortunately negatively impacted by two primary complications, graft-versus-host disease and severe infections, which hinder overall survival. We view the prevention of these adverse effects as the key to a better prognosis for these patients."
MaaT033 is designed to restore and maintain a healthy gut microbiome in patients with severe dysbiosis as a result of intensive chemotherapy and antibiotic treatment. Developed as an oral formulation in lyophilized capsules, its proprietary targeted-delivery design is conceived to optimize the product’s engraftment in the patient’s gut and its interaction with the immune system. Thanks to its high bacterial richness and ButycoreTM content, the product aims to reorient the gut microbial network towards immune homeostasis and restore the microbiome’s intestinal barrier function against infections.
"We know from previous studies that AML patients are highly dysbiotic as a result of intensive chemotherapy and antibiotic therapy. From the CIMON trial data, we can be confident that MaaT033 results in robust levels of engraftment in the gut of AML patients at the targeted dose," said Prof. Christian Recher, Professor of Hematology at the Toulouse University Hospital/IUCT-Oncopole (France) and Principal Investigator of the study. "This strong foundational data supports the launch of the next phase evaluating MaaT033 in preventing allo-HSCT complications in this patient population."
The CIMON Phase 1b trial (NCT04150393) was an open-label, dose-ranging study investigating the maximum tolerated dose of MaaT033 in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy. The trial enrolled 21 patients in four dose escalation cohorts (up to three capsules a day for 14 days) across six sites in France. The trial allowed to select the recommended dose for MaaT033, which remains confidential at this stage. MaaT033 showed rapid and persistent engraftment with the detection of more than 60% of the MaaT033 microbial communities (OTUs) in the patient’s gut post-exposure at the selected dose. Substantial engraftment was maintained during the treatment period and for at least three weeks after the end of treatment (last measure). Good tolerability of the candidate was also observed in this immunocompromised population, with only four serious adverse events (SAE) considered as unrelated to the treatment and one possibly related SAE (an infectious diarrhea event with no detection of the causal pathogen in the administered MaaT033 and patient recovery within four days). This is in line with the expected AE profile with standard of care treatments in this fragile population.
MaaT Pharma has performed a Scientific Advice procedure with the European Medicine Agency and will move forward with preparations for a Phase 2/3 randomized, double-blind, placebo-controlled study in 340 patients, that will assess safety and tolerability of MaaT033 before and after allo-HSCT, as well as the efficacy of the candidate in improving overall survival and prevention of allo-HSCT complications. The trial initiation is planned by end of 2022. This is in line with the program announced during the Company’s IPO in November 2021, and part of the funding raised during the IPO is allocated to the clinical development of MaaT033.
The Phase 1b CIMON topline data will be presented and discussed by Prof. Mohamad Mohty (Professor at Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department, Saint-Antoine Hospital, AP-HP, France) during the Company’s upcoming Virtual R&D Day, which will be held on Tuesday June 7, 2022 (register here).
Complete trial results will be submitted for presentation and/or publication in a peer-reviewed forum.
About MaaT033
MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem TherapyTM. 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 ButycoreTM species.