On December 11, 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 detailed results from the completed Phase 1b CIMON trial with MaaT033 at the Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans, U.S.
To access the abstract, please click here (Press release, MaaT Pharma, DEC 11, 2022, View Source [SID1234625026]).
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"MaaT Pharma’s mission is to improve cancer patients’ lives by driving innovation in the microbiome therapeutics field," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "These positive Phase 1b results reinforces the strong potential for our MET oral formulation, MaaT033, and we plan to investigate it as an adjunctive and maintenance treatment in patients with hematological malignancies."
Prof. Mohamad Mohty added, "Allo-HSCT is often the only curative approach for patients with hematological malignancies such as acute leukemia. Evidence of a significant reduction in the risk of infection and GvHD-related mortality following stem cell transplantation has been associated with a higher gut microbiome diversity. Our ability to maintain or induce a high richness, and a high diversity gut microbiome would be key to prevent or minimize these adverse effects and contribute to a better overall prognosis for these patients."
Key clinical findings with MaaT033 in Phase 1b study CIMON
In the dose-finding Phase 1b CIMON trial, 21 patients with acute myeloid leukemia (AML) were treated with MaaT033 and evaluated for safety, tolerability, and initial signs of microbial species engraftment.
MaaT033 was shown to be safe and tolerable in 21 patients. 4 severe adverse events (SAEs) were reported in 4 patients, only one considered as possibly related by the investigator.
Treatment with MaaT033 induced increased microbiota richness as well as strong and persistent engraftment in cohorts 3 and 4 of the dose escalation study, which consisted in the intake of 3 capsules of the drug candidate per day.
Engraftment following MaaT033 treatment correlated with increased anti-inflammatory marker levels and reduced inflammatory marker levels.
Detailed results from the Phase 1b CIMON trial were presented in a poster on December 11 at the ASH (Free ASH Whitepaper) Annual Meeting by Prof. Mohamad Mohty, Head of the Clinical Hematology and Cellular Department at the Saint-Antoine Hospital and Sorbonne University. As previously announced, MaaT Pharma is currently preparing a pivotal Phase IIb randomized, double-blind, placebo-controlled to evaluate MaaT033’s safety, engraftment, and efficacy in improving overall survival at 12 months and preventing complications in patients with blood cancers receiving hematopoietic stem cell transplantation. Initiation should take place shortly and the Company will provide a detailed status update in January 2023.
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.