{"id":13260,"date":"2024-10-15T07:31:19","date_gmt":"2024-10-15T05:31:19","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=13260"},"modified":"2024-10-15T07:31:19","modified_gmt":"2024-10-15T05:31:19","slug":"15-octobre-2024-maat-pharma-annonce-la-fin-du-recrutement-de-son-essai-de-phase-3-ares-pour-maat013-dans-le-traitement-de-la-maladie-aigue-du-greffon-contre-lhote","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/15-octobre-2024-maat-pharma-annonce-la-fin-du-recrutement-de-son-essai-de-phase-3-ares-pour-maat013-dans-le-traitement-de-la-maladie-aigue-du-greffon-contre-lhote\/","title":{"rendered":"15 octobre 2024 : MaaT Pharma annonce la fin du recrutement de son essai de Phase 3 ARES pour MaaT013 dans le traitement de la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te"},"content":{"rendered":"[vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb column_margin=\u00a0\u00bbdefault\u00a0\u00bb column_direction=\u00a0\u00bbdefault\u00a0\u00bb column_direction_tablet=\u00a0\u00bbdefault\u00a0\u00bb column_direction_phone=\u00a0\u00bbdefault\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb row_border_radius=\u00a0\u00bbnone\u00a0\u00bb row_border_radius_applies=\u00a0\u00bbbg\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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background_hover_color_opacity=\u00a0\u00bb1&Prime; column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb column_link_target=\u00a0\u00bb_self\u00a0\u00bb gradient_direction=\u00a0\u00bbleft_to_right\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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 bg_image_animation=\u00a0\u00bbnone\u00a0\u00bb border_type=\u00a0\u00bbsimple\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]\n<h3 style=\"text-align: center;\"><span style=\"color: #283583;\">MaaT Pharma annonce la fin du recrutement de son essai de Phase 3 ARES pour MaaT013 dans le traitement de la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te<\/span><\/h3>\n[\/vc_column_text]<div class=\"nectar-fancy-ul\" data-list-icon=\"icon-salient-thin-line\" data-animation=\"false\" data-animation-delay=\"0\" data-color=\"accent-color\" data-spacing=\"default\" data-alignment=\"left\"> \n<ul>\n<li>Dernier patient trait\u00e9 dans l&rsquo;essai clinique de Phase 3 ARES de MaaT Pharma<\/li>\n<li>Publication des premiers r\u00e9sultats d\u00e9sormais attendue en janvier 2025<\/li>\n<li>Avis positif du DSMB pour l&rsquo;essai de Phase 3 ARES au T4 2023, avec un rapport b\u00e9n\u00e9fice\/risque favorable et une <em>\u00ab\u00a0<\/em><em>efficacit\u00e9 <\/em><em>\u00e9lev\u00e9e <\/em><em>et faible toxicit\u00e9<\/em><em>\u00bb<\/em><\/li>\n<li>Initiation du processus d&rsquo;enregistrement avec une soumission pr\u00e9vue en 2025 en Europe<\/li>\n<\/ul>\n <\/div>[\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_tablet=\u00a0\u00bbinherit\u00a0\u00bb column_padding_phone=\u00a0\u00bbinherit\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb column_element_spacing=\u00a0\u00bbdefault\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; background_hover_color_opacity=\u00a0\u00bb1&Prime; column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb column_link_target=\u00a0\u00bb_self\u00a0\u00bb gradient_direction=\u00a0\u00bbleft_to_right\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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 bg_image_animation=\u00a0\u00bbnone\u00a0\u00bb border_type=\u00a0\u00bbsimple\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 column_margin=\u00a0\u00bbdefault\u00a0\u00bb column_direction=\u00a0\u00bbdefault\u00a0\u00bb column_direction_tablet=\u00a0\u00bbdefault\u00a0\u00bb column_direction_phone=\u00a0\u00bbdefault\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb row_border_radius=\u00a0\u00bbnone\u00a0\u00bb row_border_radius_applies=\u00a0\u00bbbg\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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background_hover_color_opacity=\u00a0\u00bb1&Prime; column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb column_link_target=\u00a0\u00bb_self\u00a0\u00bb gradient_direction=\u00a0\u00bbleft_to_right\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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 bg_image_animation=\u00a0\u00bbnone\u00a0\u00bb border_type=\u00a0\u00bbsimple\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]<strong><span style=\"color: #283583;\">Lyon, France, 15 octobre 2024 \u2013 7h30 CET \u2013 <a href=\"https:\/\/maat.swebwp.oci.eu\/\">MaaT Pharma<\/a> (EURONEXT\u00a0: MAAT &#8211; la \u00ab\u00a0Soci\u00e9t\u00e9\u00a0\u00bb), soci\u00e9t\u00e9 de biotechnologies en stade clinique avanc\u00e9, leader dans le d\u00e9veloppement de Microbiome Ecosystem Therapies<sup>TM<\/sup> (MET)<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a> visant \u00e0 am\u00e9liorer la survie des patients atteints de cancers gr\u00e2ce \u00e0 la modulation du syst\u00e8me immunitaire, <\/span><\/strong>annonce aujourd&rsquo;hui la fin du recrutement de son essai clinique de Phase 3 destin\u00e9 \u00e0 \u00e9valuer son candidat-m\u00e9dicament le plus avanc\u00e9, MaaT013, pour le traitement de la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te (aGvH) r\u00e9fractaire aux st\u00e9ro\u00efdes et r\u00e9fractaire ou intol\u00e9rante au ruxolitinib (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04769895\">NCT04769895<\/a>). Cet accomplissement constitue l\u2019une des \u00e9tapes les plus importantes dans le d\u00e9veloppement de la Soci\u00e9t\u00e9 et les premiers r\u00e9sultats, dont le crit\u00e8re d\u2019\u00e9valuation principal de l\u2019\u00e9tude (Taux de r\u00e9ponse globale gastro-intestinal), sont d\u00e9sormais attendus pour janvier 2025.<\/p>\n<p><strong>Herv\u00e9 Affagard, directeur g\u00e9n\u00e9ral et co-fondateur de MaaT Pharma d\u00e9clare :<\/strong> <em>\u00ab La fin des recrutements de la Phase 3 marque une \u00e9tape majeure dans notre mission d&rsquo;am\u00e9liorer le pronostic des patients atteints de cancer du sang et r\u00e9affirme notre engagement envers la communaut\u00e9 de la GvH. MaaT013 permet une modulation du syst\u00e8me immunitaire cibl\u00e9e en r\u00e9tablissant l&rsquo;\u00e9quilibre du microbiote intestinal et en minimisant les risques d&rsquo;effets ind\u00e9sirables fr\u00e9quemment associ\u00e9s aux traitements immunosuppresseurs conventionnels. Nous sommes convaincus que MaaT013 pourrait devenir la premi\u00e8re th\u00e9rapie approuv\u00e9e permettant la modulation immunitaire induite par le microbiote en oncologie, ouvrant<\/em> <em>ainsi la voie \u00e0 la cr\u00e9ation d\u2019un nouveau pilier th\u00e9rapeutique pour une large cible de cancers.\u00a0\u00bb<\/em><\/p>\n<p>ARES est une \u00e9tude europ\u00e9enne, pivotale de Phase 3 multicentrique, ouverte, \u00e0 un seul bras, \u00e9valuant la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9 de MaaT013 chez des patients atteints d\u2019aGvH gastrointestinale r\u00e9fractaires aux st\u00e9ro\u00efdes et \u00e0 ruxolitinib. L&rsquo;\u00e9tude avait pr\u00e9vu de recruter jusqu\u2019\u00e0 75 patients afin d\u2019anticiper d\u2019\u00e9ventuels abandons en cours d\u2019\u00e9tude, et la Soci\u00e9t\u00e9 a atteint son objectif en recrutant les 66 patients \u00e9valuables, n\u00e9cessaires pour une analyse pr\u00e9cise du crit\u00e8re d&rsquo;\u00e9valuation principal. La Soci\u00e9t\u00e9 a annonc\u00e9 au quatri\u00e8me trimestre 2023 <a href=\"https:\/\/maat.swebwp.oci.eu\/fr\/26-octobre-2023-maat-pharma-annonce-les-conclusions-positives-du-dsmb-renforcant-la-confiance-dans-lessai-de-phase-3-en-cours-evaluant-maat013-dans-la-maladie-aigue-du-greffon-contre-l\/\">l\u2019avis positif du Comit\u00e9 ind\u00e9pendant de surveillance et de s\u00e9curit\u00e9 (Data Safety Monitoring Board &#8211; DSMB)<\/a> concernant l&rsquo;essai de Phase 3 ARES, qui a conclu \u00e0 un rapport b\u00e9n\u00e9fice\/risque favorable, avec <em>\u00ab une efficacit\u00e9 \u00e9lev\u00e9e et une faible toxicit\u00e9 \u00bb.<\/em> En parall\u00e8le, MaaT013 est disponible depuis 5 ans dans le cadre d\u2019un programme d\u2019acc\u00e8s compassionnel dans 6 pays en Europe pour traiter la maladie aigu\u00eb du greffon contre l\u2019h\u00f4te, avec plus de 180 patients trait\u00e9s en toute s\u00e9curit\u00e9 \u00e0 ce jour.<\/p>\n<p><strong>Les prochaines \u00e9tapes pour MaaT013 dans l\u2019aGvH sont les suivantes :<\/strong><\/p>\n<ul>\n<li><strong>D\u00e9but d\u00e9cembre 2024\u00a0:<\/strong> La Soci\u00e9t\u00e9 organisera une discussion avec des experts portant sur les donn\u00e9es actualis\u00e9es du programme d&rsquo;acc\u00e8s compassionnel en Europe pour MaaT013 dans le traitement de l&rsquo;aGvH.<\/li>\n<li><strong>Janvier 2025 :<\/strong>\n<ul>\n<li>Publication des premiers r\u00e9sultats dont le crit\u00e8re principal d\u2019\u00e9valuation \u00e0 savoir le Taux de r\u00e9ponse globale gastro-intestinal (GI-ORR) \u00e0 J28.<\/li>\n<li>La Soci\u00e9t\u00e9 organisera une discussion avec des experts sur les r\u00e9sultats de l&rsquo;essai de Phase 3.<\/li>\n<\/ul>\n<\/li>\n<li><strong>D\u2019ici la fin 2025\u00a0:<\/strong>Publication des r\u00e9sultats portant sur les crit\u00e8res secondaires dont le taux de survie globale \u00e0 1 an<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> Microbiome Ecosystem Therapy<sup>TM<\/sup>: Microbioth\u00e9rapie \u00e0 Ecosyst\u00e8me Complet[\/vc_column_text][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_tablet=\u00a0\u00bbinherit\u00a0\u00bb column_padding_phone=\u00a0\u00bbinherit\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb column_element_spacing=\u00a0\u00bbdefault\u00a0\u00bb background_color_opacity=\u00a0\u00bb1&Prime; 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background_hover_color_opacity=\u00a0\u00bb1&Prime; column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb column_link_target=\u00a0\u00bb_self\u00a0\u00bb gradient_direction=\u00a0\u00bbleft_to_right\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3&Prime; 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 bg_image_animation=\u00a0\u00bbnone\u00a0\u00bb border_type=\u00a0\u00bbsimple\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]<span style=\"color: #283583;\"><strong>A propos de MaaT Pharma<\/strong><\/span><\/p>\n<p>MaaT Pharma est une soci\u00e9t\u00e9 de biotechnologies au stade clinique qui a mis au point une approche compl\u00e8te pour restaurer la symbiose microbiote\/h\u00f4te des patients atteints de cancers. Engag\u00e9e dans le traitement des cancers et de la maladie du greffon contre l\u2019h\u00f4te (GvH), une complication grave survenant apr\u00e8s une greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques, MaaT Pharma a lanc\u00e9 en mars 2022 en Europe un essai clinique de Phase 3 chez des patients atteints de GvH aigu\u00eb, apr\u00e8s avoir r\u00e9alis\u00e9 la preuve de concept de son approche dans un essai clinique de Phase 2. Sa puissante plateforme de d\u00e9couverte et d\u2019analyse, gutPrint\u00ae soutient le d\u00e9veloppement de son portefeuille de produits et son extension \u00e0 des indications plus larges, en aidant \u00e0 d\u00e9terminer de nouvelles cibles th\u00e9rapeutiques, \u00e0 \u00e9valuer les m\u00e9dicaments candidats et \u00e0 identifier des biomarqueurs pour la prise en charge de pathologies impliquant le microbiote. Les <em>Microbiome Ecosystem Therapies<sup>TM <\/sup><\/em>(Microbioth\u00e9rapies \u00e0 \u00e9cosyst\u00e8me complet) sont toutes produites dans le cadre tr\u00e8s standardis\u00e9 d\u2019une fabrication et de contr\u00f4les qualit\u00e9 cGMP, afin de garantir en toute s\u00e9curit\u00e9 l\u2019acc\u00e8s \u00e0 la diversit\u00e9 et \u00e0 la richesse du microbiote, sous forme orale ou d\u2019<em>enema<\/em>. MaaT Pharma b\u00e9n\u00e9ficie de l\u2019engagement de scientifiques de renomm\u00e9e mondiale et de relations \u00e9tablies avec les instances r\u00e9glementaires pour faire progresser l\u2019int\u00e9gration des th\u00e9rapies \u00e0 base de microbiote dans la pratique clinique. MaaT Pharma est la premi\u00e8re soci\u00e9t\u00e9 d\u00e9veloppant des m\u00e9dicaments \u00e0 base de microbiote cot\u00e9e sur Euronext Paris (Code mn\u00e9monique\u00a0: MAAT).[\/vc_column_text][vc_column_text]<span style=\"color: #283583;\"><strong>A propos de MaaT013<\/strong><\/span><\/p>\n<p>MaaT013 est une <em>Microbiome Ecosystem Therapy<\/em> (microbioth\u00e9rapie \u00e0 \u00e9cosyst\u00e8me complet) pr\u00eate \u00e0 l\u2019emploi, standardis\u00e9e et issue d\u2019une combinaison de microbiotes de donneurs sains (pool\u00e9e). Le produit est caract\u00e9ris\u00e9 par une diversit\u00e9 et une richesse \u00e9lev\u00e9es et standardis\u00e9es des esp\u00e8ces microbiennes qu\u2019il contient et la pr\u00e9sence de Butycore<sup>TM<\/sup> (ensemble de bact\u00e9ries produisant des m\u00e9tabolites anti-inflammatoires). MaaT013 a pour but de restaurer la relation symbiotique entre le microbiote intestinal du patient et son syst\u00e8me immunitaire, afin de corriger la r\u00e9activit\u00e9 et restaurer la tol\u00e9rance des fonctions immunitaires et ainsi de r\u00e9duire l\u2019aGvH gastro-intestinale r\u00e9sistante aux st\u00e9ro\u00efdes. MaaT013 a re\u00e7u la d\u00e9signation de m\u00e9dicament orphelin de la Food and Drug Administration (FDA) aux \u00c9tats-Unis et de l&rsquo;Agence europ\u00e9enne des m\u00e9dicaments (EMA).[\/vc_column_text][vc_column_text]<span style=\"color: #283583;\"><strong>A propos de la maladie du greffon contre l&rsquo;h\u00f4te aigu\u00eb<\/strong><\/span><\/p>\n<p>L\u2019aGvH survient chez les patients dans les 100 jours apr\u00e8s une greffe de cellules souches ou de moelle osseuse. Les cellules greff\u00e9es \u00ab\u00a0attaquent\u00a0\u00bb le receveur, provoquant une inflammation de la peau, du foie et\/ou du tractus gastro-intestinal. L\u2019aGvH \u00e0 dominante gastro-intestinale entra\u00eene des diarrh\u00e9es tr\u00e8s abondantes pouvant mettre la vie du patient en danger. Le traitement th\u00e9rapeutique standard de premi\u00e8re ligne pour traiter l\u2019aGvH est le recours aux st\u00e9ro\u00efdes. Si les patients ne r\u00e9pondent pas aux st\u00e9ro\u00efdes, ils sont consid\u00e9r\u00e9s comme r\u00e9sistants (SR) et d&rsquo;autres traitements peuvent \u00eatre administr\u00e9s. Actuellement, le seul m\u00e9dicament approuv\u00e9 pour le traitement de l\u2019aGvH SR, apr\u00e8s \u00e9chec de la corticoth\u00e9rapie, est le ruxolitinib. Pour cette indication, ce dernier est actuellement approuv\u00e9 aux \u00c9tats-Unis et a \u00e9galement re\u00e7u l&rsquo;approbation du Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) de l&rsquo;Agence europ\u00e9enne des m\u00e9dicaments (EMA) en Mars 2022.[\/vc_column_text][vc_column_text]<span style=\"color: #283583;\"><strong>Donn\u00e9es prospectives <\/strong><\/span><br \/>\nCe communiqu\u00e9 de presse contient des d\u00e9clarations prospectives. Toutes les d\u00e9clarations autres que les \u00e9nonc\u00e9s de faits historiques inclus dans le pr\u00e9sent communiqu\u00e9 de presse au sujet d&rsquo;\u00e9v\u00e9nements futurs sont sujettes \u00e0 (i) des changements sans pr\u00e9avis et (ii) des facteurs ind\u00e9pendants de la volont\u00e9 de la Soci\u00e9t\u00e9. Ces d\u00e9clarations peuvent comprendre, sans s&rsquo;y limiter, tout \u00e9nonc\u00e9 pr\u00e9c\u00e9d\u00e9, suivi ou incluant des mots tels que \u00ab cibler \u00bb, \u00ab croire \u00bb, \u00ab s&rsquo;attendre \u00e0 \u00bb, \u00ab viser \u00bb, \u00ab avoir l&rsquo;intention de \u00bb, \u00ab pouvoir \u00bb, \u00ab pr\u00e9voir \u00bb, \u00ab estimer \u00bb, \u00ab planifier \u00bb, \u00ab projeter \u00bb, \u00ab vouloir \u00bb, \u00ab pouvoir avoir \u00bb, \u00ab susceptible de \u00bb, \u00ab probable \u00bb, \u00ab devoir \u00bb, \u00ab pr\u00e9visions \u00bb et d\u2019autres mots et termes ayant un sens similaire ou la forme n\u00e9gative qui en d\u00e9coule. 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