Nearly 20,000 allo-HSCT transplantations per year in Europe were reported in 2021 by the European Society for Blood and Marrow Transplantation (EBMT) and continue to increase. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).Ībout Allogeneic hematopoietic stem cell transplantation (allo-HSCT)Īllogeneic hematopoietic stem cell transplantation (allo-HSCT) for liquid tumors can replace cancerous cells, but the harsh conditioning treatments damage the gut microbiome, which has been linked to decreased survival, increased risk of graft-vs-host disease, and infections due to impaired immune function. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033, a donor-derived,high-richness,high-diversity oral Microbiome Ecosystem Therapy TM containing anti-inflammatory Butycore TM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. "We look forward to continuing to collaborate closely with the regulatory agencies to accelerate the development of safe and innovative microbiome therapies." "The EMA's decision to grant orphan drug designation to MaaT033, our second clinical-stage asset and first-in-class therapeutics, recognizes the need for new treatment options for patients with liquid tumors and highlights the potential of microbiome-based drugs further strengthening the value of our clinical assets," stated Philippe Moyen, COO of MaaT Pharma. This is the first ODD granted for MaaT033 and the third to date for the Company, which has already obtained ODD status for MaaT013 in the US and Europe. Microbiome Ecosystem Therapies TM (MET) dedicated to improving survival outcomes for patients with cancer, announced that the European Medicines Agency (EMA) has granted MaaT033 orphan drug designation aiming to improve overall survival in patients undergoing HSCT and has recognized the significant benefit that MaaT033 could therefore bring to this patient's population.
Lyon, France, September 7, 2023, 7:30am CET - MaaT Pharma (EURONEXT: MAAT - the "Company"), a clinical-stage biotechnology company and a leader in the development of The status offers key benefits including market exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
MaaT033 (capsule), which is being developed as an adjunctive and maintenance therapy to improve overall survival in allo-HSCT, has received orphan drug designation (ODD) status from the European Medicines Agency (EMA).MaaT Pharma Announces European Medicines Agency Granted MaaT033 Orphan Drug Designation aiming to improve overall survival in patients undergoing Hematopoietic Stem Cell transplantation
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