{"id":4492,"date":"2019-04-09T11:48:38","date_gmt":"2019-04-09T11:48:38","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4492"},"modified":"2023-09-25T14:01:48","modified_gmt":"2023-09-25T14:01:48","slug":"maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-announces-second-positive-dsmb-safety-assessment-of-phase-ii-heracles-study-in-acute-gvhd\/","title":{"rendered":"MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD"},"content":{"rendered":"[vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/6&Prime; tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb2\/3&Prime; tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]\n<p style=\"text-align: center;\"><strong>MaaT Pharma Announces Second Positive DSMB Safety Assessment<br \/>\n<\/strong><strong>of Phase II HERACLES Study in Acute GvHD<\/strong><\/p>\n[\/vc_column_text][vc_column_text]<strong>Lyon, France, April 09, 2019<\/strong> \u2013 MaaT Pharma 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:\/\/maat.swebwp.oci.eu\/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.[\/vc_column_text][nectar_single_testimonial testimonial_style=\u00a0\u00bbsmall_modern\u00a0\u00bb image=\u00a0\u00bb1711&Prime; color=\u00a0\u00bbExtra-Color-2&Prime; quote=\u00a0\u00bb\u201cThe high mortality rate of up to 80% after 6 months in gastrointestinal-predominant aGvHD poses a significant unmet medical need and we believe that MaaT013 will improve these patients\u2019 outcomes through a differentiated approach of restoring their immune homeostasis,\u201d<\/p>\n<p>\u00ab\u00a0The relevance of the microbiome in hemato-oncological diseases is increasingly recognized by the medical community and our mission is to develop the first, safe microbiome-based product to help patients with no other options. We look forward to communicating the top-line data of this trial later this year.\u201d\u00a0\u00bb name=\u00a0\u00bbcommented Herv\u00e9 Affagard\u00a0\u00bb subtitle=\u00a0\u00bbCo-founder and CEO of MaaT Pharma.\u00a0\u00bb][vc_column_text]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:\/\/maat.swebwp.oci.eu\/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>[\/vc_column_text][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/6&Prime; tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][\/vc_row][vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/1&Prime; tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017&Prime; style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n<h3>About <em>HERACLES<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]<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 MaaT Pharma\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.[\/vc_column_text][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017&Prime; style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n<h3>About <em>MaaT013<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]<strong>MaaT013<\/strong> is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharma\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.[\/vc_column_text][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017&Prime; style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n<h3>About <em>MaaT Pharma<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]<strong>MaaT Pharma<\/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, MaaT Pharma 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. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb top_padding=\u00a0\u00bb3%\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb shape_type=\u00a0\u00bb\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb 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column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][nectar_btn size=\u00a0\u00bbmedium\u00a0\u00bb open_new_tab=\u00a0\u00bbtrue\u00a0\u00bb button_style=\u00a0\u00bbsee-through-2&Prime; color_override=\u00a0\u00bb#5bc0cc\u00a0\u00bb hover_color_override=\u00a0\u00bb#5bc0cc\u00a0\u00bb hover_text_color_override=\u00a0\u00bb#ffffff\u00a0\u00bb icon_family=\u00a0\u00bbnone\u00a0\u00bb url=\u00a0\u00bbhttps:\/\/maat.swebwp.oci.eu\/wp-content\/uploads\/2019\/04\/maat-pharma-second-DSMB.pdf\u00a0\u00bb text=\u00a0\u00bbDownload our Press Release (PDF)\u00a0\u00bb][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/4&Prime; 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tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"category_press":[],"year_press":[51],"class_list":{"0":"post-4492","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-communiques-de-presse-fr","7":"year_press-51"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD - MaaT Pharma<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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