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MaaT Pharma announces positive DSMB safety review and continuation of its Phase II HERACLES Study


Independent Data Safety Monitoring Board (DSMB) recommends to continue HERACLES study without modification


Lyon, France, February 5, 2019 – MaaT Pharma announced today that its independent Data and Safety Monitoring Board (DSMB) completed its first safety assessment of the company’s ongoing Phase II HERACLES study (NCT03359980) with lead biotherapeutic MaaT013 in steroid-resistant, gastrointestinal-predominant, acute Graft-versus-Host-Disease (SR GI aGvHD) after allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT). The DSMB confirmed the absence of safety issues during the trial from initiation until the first safety evaluation milestone of five patients treated. Enrollment is on schedule with sites recruiting in France and Poland. Additional sites in three other European countries are scheduled to begin recruitment in early 2019. MaaT013 is the first full-ecosystem, off-the-shelf biotherapeutic emerging from MaaT Pharma’s Microbiome Restoration Biotherapeutic (MMRB) platform and has been granted orphan drug designation by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).


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