{"id":4492,"date":"2019-04-09T11:48:38","date_gmt":"2019-04-09T11:48:38","guid":{"rendered":"https:\/\/www.maatpharma.com\/?p=4492"},"modified":"2025-11-26T14:50:44","modified_gmt":"2025-11-26T12:50:44","slug":"maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd","status":"publish","type":"post","link":"https:\/\/www.maatpharma.com\/fr\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","title":{"rendered":"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD"},"content":{"rendered":"<p style=\"text-align: center\"><strong>黑料社 Announces Second Positive DSMB Safety Assessment<br \/>\n<\/strong><strong>of Phase II HERACLES Study in Acute GvHD<\/strong><\/p>\n<p><strong>Lyon, France, April 09, 2019<\/strong> \u2013 黑料社 announced today that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03359980?term=NCT03359980&amp;rank=1\" target=\"_blank\" rel=\"noopener noreferrer\">NCT03359980<\/a>). The HERACLES trial inverstigates the use of 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 second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the <a href=\"https:\/\/www.maatpharma.com\/maat-pharma-announces-positive-dsmb-safety-review-and-continuation-of-its-phase-ii-heracles-study-in-acute-gvhd\/\" target=\"_blank\" rel=\"noopener noreferrer\">first review<\/a>. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.Seperately, the Company announced the presentation of the detailed protocol information on the HERACLES study in a poster at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation in Frankfurt, Germany, held from March 24th \u2013 27th, 2019. The full poster can be accessed on the Company website <a href=\"https:\/\/www.maatpharma.com\/heracles-a-phase-ii-single-arm-prospective-study-to-assess-the-efficacy-of-fecal-microbiota-transfer-fmt-in-the-treatment-of-steroid-refractory-gastro-intestinal-predominant-agvhd-post-allo-hsct\/\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>here<\/strong><\/a><\/p>\n<h3>About <em>HERACLES<\/em><\/h3>\n<p><strong>The HERACLES study<\/strong> is a multi-center, single-arm, open-label study, enrolling <strong>32 patients<\/strong> to evaluate the efficacy and safety of 黑料社\u2019s lead microbiome restoration drug candidate <strong>MaaT013<\/strong> in steroid-resistant gut predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction induced by the donor cells derived from the hematopoietic stem cell graft against the host and have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition.<\/p>\n<h3>About <em>MaaT013<\/em><\/h3>\n<p><strong>MaaT013<\/strong> is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using 黑料社\u2019s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company\u2019s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.<\/p>\n<h3>About <em>黑料社<\/em><\/h3>\n<p><strong>黑料社<\/strong>, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, 黑料社 has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD Lyon, France, April 09, 2019 \u2013 黑料社 announced today that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (NCT03359980). The HERACLES trial inverstigates the use of 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 second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the first review. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.Seperately, the Company announced the presentation of the detailed protocol information on the HERACLES study in a poster at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation in Frankfurt, Germany, held from March 24th \u2013 27th, 2019. The full poster can be accessed on the Company website here About HERACLES The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of 黑料社\u2019s lead microbiome restoration drug candidate MaaT013 in steroid-resistant gut predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction induced by the donor cells derived from the hematopoietic stem cell graft against the host and have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition. About MaaT013 MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using 黑料社\u2019s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company\u2019s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About 黑料社 黑料社, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, 黑料社 has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[21],"tags":[],"category_press":[],"year_press":[51],"class_list":["post-4492","post","type-post","status-publish","format-standard","hentry","category-communiques-de-presse-fr","year_press-51"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - 黑料社<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - 黑料社\" \/>\n<meta property=\"og:description\" content=\"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD Lyon, France, April 09, 2019 \u2013 黑料社 announced today that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (NCT03359980). The HERACLES trial inverstigates the use of 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 second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the first review. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.Seperately, the Company announced the presentation of the detailed protocol information on the HERACLES study in a poster at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation in Frankfurt, Germany, held from March 24th \u2013 27th, 2019. The full poster can be accessed on the Company website here About HERACLES The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of 黑料社\u2019s lead microbiome restoration drug candidate MaaT013 in steroid-resistant gut predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction induced by the donor cells derived from the hematopoietic stem cell graft against the host and have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition. About MaaT013 MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using 黑料社\u2019s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company\u2019s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About 黑料社 黑料社, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, 黑料社 has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/\" \/>\n<meta property=\"og:site_name\" content=\"黑料社\" \/>\n<meta property=\"article:published_time\" content=\"2019-04-09T11:48:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-26T12:50:44+00:00\" \/>\n<meta name=\"author\" content=\"黑料社\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"黑料社\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\\\/\"},\"author\":{\"name\":\"黑料社\",\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/#\\\/schema\\\/person\\\/2a1b26915c84fdbc8c7a8ebe36530d34\"},\"headline\":\"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD\",\"datePublished\":\"2019-04-09T11:48:38+00:00\",\"dateModified\":\"2025-11-26T12:50:44+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\\\/\"},\"wordCount\":533,\"publisher\":{\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/#organization\"},\"articleSection\":[\"Communiqu\u00e9s de presse\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.maatpharma.com\\\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\\\/\",\"url\":\"https:\\\/\\\/www.maatpharma.com\\\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\\\/\",\"name\":\"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - 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黑料社","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","og_locale":"fr_FR","og_type":"article","og_title":"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - 黑料社","og_description":"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD Lyon, France, April 09, 2019 \u2013 黑料社 announced today that the independent Data and Safety Monitoring Board (DSMB) recommended the continuation, without amendment, of the ongoing Phase II HERACLES study (NCT03359980). The HERACLES trial inverstigates the use of 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 second review assessed the safety of MaaT013 after 10 patients treated, reinforcing the absence of safety issues during the trial as confirmed after the first review. Enrollment of patients in the trial continues as planned with additional sites recently opened in Germany and Italy. As of today a total of 13 patients have been treated in the protocol.Seperately, the Company announced the presentation of the detailed protocol information on the HERACLES study in a poster at the 45th Annual Meeting of the European Society for Blood and Marrow Transplantation in Frankfurt, Germany, held from March 24th \u2013 27th, 2019. The full poster can be accessed on the Company website here About HERACLES The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of 黑料社\u2019s lead microbiome restoration drug candidate MaaT013 in steroid-resistant gut predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction induced by the donor cells derived from the hematopoietic stem cell graft against the host and have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition. About MaaT013 MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using 黑料社\u2019s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company\u2019s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use. About 黑料社 黑料社, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, 黑料社 has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. 黑料社 benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.","og_url":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","og_site_name":"黑料社","article_published_time":"2019-04-09T11:48:38+00:00","article_modified_time":"2025-11-26T12:50:44+00:00","author":"黑料社","twitter_card":"summary_large_image","twitter_misc":{"\u00c9crit par":"黑料社","Dur\u00e9e de lecture estim\u00e9e":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/#article","isPartOf":{"@id":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/"},"author":{"name":"黑料社","@id":"https:\/\/www.maatpharma.com\/#\/schema\/person\/2a1b26915c84fdbc8c7a8ebe36530d34"},"headline":"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD","datePublished":"2019-04-09T11:48:38+00:00","dateModified":"2025-11-26T12:50:44+00:00","mainEntityOfPage":{"@id":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/"},"wordCount":533,"publisher":{"@id":"https:\/\/www.maatpharma.com\/#organization"},"articleSection":["Communiqu\u00e9s de presse"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","url":"https:\/\/www.maatpharma.com\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","name":"黑料社 Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - 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