{"id":15016,"date":"2025-04-08T07:30:58","date_gmt":"2025-04-08T05:30:58","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=15016"},"modified":"2025-04-08T07:30:58","modified_gmt":"2025-04-08T05:30:58","slug":"8-avril-2025-maat-pharma-annonce-le-resultat-positif-de-lanalyse-intermediaire-de-securite-a-la-suite-de-la-revue-du-dsmb-pour-lessai-clinique-de-phase-2b-en-cours-evaluant-maat033-pour-l","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/8-avril-2025-maat-pharma-annonce-le-resultat-positif-de-lanalyse-intermediaire-de-securite-a-la-suite-de-la-revue-du-dsmb-pour-lessai-clinique-de-phase-2b-en-cours-evaluant-maat033-pour-l\/","title":{"rendered":"8 avril 2025 : MaaT Pharma annonce le r\u00e9sultat positif de l\u2019analyse interm\u00e9diaire de s\u00e9curit\u00e9 \u00e0 la suite de la revue du DSMB pour l&rsquo;essai clinique de Phase 2b en cours \u00e9valuant MaaT033 pour les patients recevant une allo-GCSH"},"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;\"><span class=\"TextRun SCXW54512012 BCX0\" lang=\"FR-FR\" xml:lang=\"FR-FR\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW54512012 BCX0\">MaaT Pharma annonce le r\u00e9sultat positif de l\u2019analyse interm\u00e9diaire de s\u00e9curit\u00e9 suite \u00e0 la revue du DSMB pour l&rsquo;essai clinique de Phase 2b en cours \u00e9valuant MaaT033 pour les patients recevant une allo-GCSH<\/span><\/span><\/span><\/h3>\n[\/vc_column_text][vc_column_text]\n<ul>\n<li><span style=\"color: #283583;\">Le DSMB (Data Safety and Monitoring Board), un comit\u00e9 d\u2019experts ind\u00e9pendants, a examin\u00e9 les donn\u00e9es apr\u00e8s la lev\u00e9e d\u2019aveugle dans le cadre d\u2019une analyse interm\u00e9diaire cl\u00e9 en termes de s\u00e9curit\u00e9 et a recommand\u00e9 la poursuite de l&rsquo;essai sans modification.<\/span><\/li>\n<li><span style=\"color: #283583;\">MaaT033, un candidat-m\u00e9dicament de forme orale d\u00e9velopp\u00e9 \u00e0 partir de multi-donneurs pour une utilisation ambulatoire, continue de d\u00e9montrer un profil de s\u00e9curit\u00e9 favorable et une bonne tol\u00e9rance.<\/span><\/li>\n<\/ul>\n[\/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]<strong><span style=\"color: #283583;\">Lyon, France, 8 avril 2025 \u2013 7h30 CET \u2013 <a href=\"https:\/\/maat.swebwp.oci.eu\/fr\/\">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) visant \u00e0 am\u00e9liorer la survie des patients atteints de cancers gr\u00e2ce \u00e0 la modulation du syst\u00e8me immunitaire, <\/span><\/strong>annonce aujourd\u2019hui le r\u00e9sultat positif de l\u2019analyse interm\u00e9diaire de s\u00e9curit\u00e9, une \u00e9tape cl\u00e9, de l\u2019essai de Phase 2b PHOEBUS. Cet essai est le plus large essai contr\u00f4l\u00e9 randomis\u00e9 \u00e9valuant une th\u00e9rapie issue du microbiote en oncologie men\u00e9 \u00e0 ce jour dans le monde. L\u2019essai compare l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 de MaaT033 (bras exp\u00e9rimental) par rapport \u00e0 un placebo chez des patients recevant une greffe allog\u00e9nique de cellules souches h\u00e9matopo\u00ef\u00e9tiques (allo-GCSH).<\/p>\n<p>Apr\u00e8s une allo-GCSH, les patients sont particuli\u00e8rement vuln\u00e9rables et expos\u00e9s \u00e0 un risque \u00e9lev\u00e9 de mortalit\u00e9 non li\u00e9e \u00e0 une rechute. Ainsi, le protocole de l\u2019\u00e9tude inclut une analyse de s\u00e9curit\u00e9 sp\u00e9cifique, d\u00e9clenchant un arr\u00eat de l\u2019\u00e9tude si un exc\u00e8s de mortalit\u00e9 pr\u00e9d\u00e9fini est observ\u00e9 dans le bras exp\u00e9rimental. Cette analyse intervient apr\u00e8s la randomisation de 30 patients recevant MaaT033 (soit environ 60 patients inclus dans l\u2019\u00e9tude) et suivis pendant 90 jours apr\u00e8s leur greffe. Cette analyse est distincte des analyses de s\u00e9curit\u00e9 continues men\u00e9es tous les six mois, et dont les r\u00e9sultats positifs ont \u00e9t\u00e9 communiqu\u00e9s pour la derni\u00e8re fois<a href=\"https:\/\/maat.swebwp.oci.eu\/fr\/21-janvier-2025-maat-pharma-annonce-le-resultat-positif-du-deuxieme-dsmb-pour-lessai-clinique-de-phase-2b-en-cours-evaluant-maat033-pour-les-patients-recevant-une-allo-gcsh\/\"> le 21 janvier 2025<\/a>. \u00c0 l\u2019issue de leur analyse apr\u00e8s lev\u00e9e d\u2019aveugle, le DSMB a conclu que l\u2019essai pouvait se poursuivre tel que pr\u00e9vu, ne montrant aucun exc\u00e8s de mortalit\u00e9 li\u00e9 \u00e0 MaaT033 \u00e0 ce jour. Ce nouvel avis positif renforce encore davantage le profil de s\u00e9curit\u00e9 de MaaT033 et soutient son utilisation dans la prise en charge des patients recevant une allo-GCSH, sans risque significatif d\u2019effets ind\u00e9sirables s\u00e9v\u00e8res.<\/p>\n<p><em>\u00ab\u00a0Nous sommes ravis de confirmer que le profil de s\u00e9curit\u00e9 de MaaT033 reste favorable. L\u2019absence confirm\u00e9e d\u2019un exc\u00e8s de mortalit\u00e9 pr\u00e9d\u00e9fini chez les patients recevant MaaT033 rev\u00eat une importance cruciale\u00a0\u00bb,<\/em> <strong>a d\u00e9clar\u00e9 le Docteur Gianfranco Pittari, PhD, Directeur M\u00e9dical de MaaT Pharma.<\/strong> <em>\u00ab\u00a0Ces patients pourraient ainsi tirer un b\u00e9n\u00e9fice consid\u00e9rable de ces th\u00e9rapies innovantes susceptibles d\u2019am\u00e9liorer les r\u00e9sultats de la greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques tout en limitant les effets ind\u00e9sirables.\u00a0\u00bb<\/em><\/p>\n<p>Le recrutement des patients se poursuit en France, Allemagne, Belgique, Espagne, Pays-Bas et au Royaume-Uni. L&rsquo;essai Phoebus est une \u00e9tude internationale, multicentrique, randomis\u00e9e, en double aveugle et contr\u00f4l\u00e9e par placebo, \u00e9valuant MaaT033, une formulation orale lyophilis\u00e9e standardis\u00e9e d\u00e9velopp\u00e9e \u00e0 partir de multi-donneurs, comme traitement adjuvant pour les patients recevant une greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques allog\u00e9niques (allo-GCSH), contre un placebo. L\u2019essai pr\u00e9voit d\u2019inclure 387 patients et devrait atteindre jusqu\u2019\u00e0 60 sites d&rsquo;investigation (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05762211\">NCT05762211<\/a>).<\/p>\n<p>S&rsquo;appuyant sur le profil de s\u00e9curit\u00e9 et d&rsquo;efficacit\u00e9 \u00e9tabli de MaaT013, la formulation en capsule MaaT033 repr\u00e9sente un atout strat\u00e9gique majeur. En tant que deuxi\u00e8me candidat issu de la plateforme de MaaT Pharma pour les th\u00e9rapies issues de donneurs (produits dits natifs), il a \u00e9t\u00e9 sp\u00e9cialement con\u00e7u pour cibler un plus grand nombre de patients gr\u00e2ce \u00e0 une administration orale. Cette approche permet non seulement une utilisation en ambulatoire, et favorise une prise en charge optimis\u00e9e des patients.<\/p>\n<p><strong>Prochaines \u00e9tapes<\/strong><\/p>\n<ul>\n<li>La prochaine analyse interm\u00e9diaire apr\u00e8s la lev\u00e9e d\u2019aveugle par le DSMB est pr\u00e9vue au troisi\u00e8me trimestre 2025, apr\u00e8s l\u2019inclusion du 120<sup>\u00e8me<\/sup> patient.<\/li>\n<li>L\u2019\u00e9valuation de s\u00e9curit\u00e9 r\u00e9guli\u00e8re du DSMB, men\u00e9e tous les six mois, est \u00e9galement attendue pour le troisi\u00e8me trimestre 2025.<\/li>\n<\/ul>\n[\/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; 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; gradient_direction=\u00a0\u00bbleft_to_right\u00a0\u00bb shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb bg_image_animation=\u00a0\u00bbnone\u00a0\u00bb][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_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\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 MaaT033<\/strong><\/span><\/p>\n<p>MaaT033 est une Microbiome Ecosystem Therapy<sup>TM<\/sup> orale issue de donneurs, standardis\u00e9e, \u00e0 haute richesse et diversit\u00e9 bact\u00e9riennes, comprenant les esp\u00e8ces anti-inflammatoires\u00a0du Butycore<sup>TM<\/sup>. MaaT033 est actuellement d\u00e9velopp\u00e9 comme traitement adjuvant pour am\u00e9liorer la survie des patients recevant une GCSH et d\u2019autres th\u00e9rapies cellulaires. Il est d\u00e9di\u00e9 \u00e0 restaurer le fonctionnement optimal du microbiote pour une utilisation en ambulatoire et \u00e0 destination d\u2019une population plus large. MaaT033 a re\u00e7u le statut de m\u00e9dicament orphelin de l\u2019Agence Europ\u00e9enne du M\u00e9dicament (EMA).[\/vc_column_text][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 biotechnologie en phase clinique avanc\u00e9e, leader dans le d\u00e9veloppement de m\u00e9dicaments issus du microbiote intestinal d\u00e9di\u00e9s \u00e0 moduler le syst\u00e8me immunitaire des patients atteints de cancer et \u00e0 am\u00e9liorer leur survie. Soutenue par une \u00e9quipe experte qui s&rsquo;engage \u00e0 faire la diff\u00e9rence pour les patients du monde entier, la Soci\u00e9t\u00e9 a \u00e9t\u00e9 fond\u00e9e en 2014 et est bas\u00e9e \u00e0 Lyon en France.<\/p>\n<p>Pionni\u00e8re dans son domaine, MaaT Pharma d\u00e9veloppe le premier candidat-m\u00e9dicament immunomodulateur bas\u00e9 sur le microbiote intestinal en oncologie, actuellement en phase 3 d\u2019\u00e9valuation clinique. Gr\u00e2ce \u00e0 ses technologies propri\u00e9taires de \u00ab pooling \u00bb (combinaison de dons de microbiotes sains) et de co-culture microbienne, MaaT Pharma d\u00e9veloppe des m\u00e9dicaments standardis\u00e9s \u00e0 haute diversit\u00e9 bact\u00e9rienne, visant \u00e0 am\u00e9liorer la survie des patients atteints de cancer. MaaT Pharma est cot\u00e9e sur Euronext Paris (MAAT) depuis 2021.[\/vc_column_text][vc_column_text]<span style=\"color: #283583;\"><strong>Donn\u00e9es prospectives<\/strong><\/span><\/p>\n<p>Ce 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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