{"id":4504,"date":"2019-02-05T12:00:31","date_gmt":"2019-02-05T12:00:31","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4504"},"modified":"2023-09-25T14:02:36","modified_gmt":"2023-09-25T14:02:36","slug":"maat-pharma-announces-positive-dsmb-safety-review-and-continuation-of-its-phase-ii-heracles-study-in-acute-gvhd","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-announces-positive-dsmb-safety-review-and-continuation-of-its-phase-ii-heracles-study-in-acute-gvhd\/","title":{"rendered":"MaaT Pharma annonce une analyse positive de s\u00e9curit\u00e9 du DSMB et la poursuite de son \u00e9tude HERACLES, une \u00e9tude de phase II sur la maladie aigu\u00eb du greffon contre l\u2019h\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″ 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″ background_hover_color_opacity=\u00a0\u00bb1″ 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″ width=\u00a0\u00bb1\/6″ 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″ background_hover_color_opacity=\u00a0\u00bb1″ 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″ width=\u00a0\u00bb2\/3″ 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

Le comit\u00e9 de surveillance et de suivi (DSMB)
\nrecommande de poursuivre l\u2019\u00e9tude HERACLES sans modifications.<\/em><\/strong><\/h3>\n[\/vc_column_text][vc_column_text]Lyon, France, 5\u00a0f\u00e9vrier\u00a02019 \u2013<\/strong> MaaT Pharma a annonc\u00e9 aujourd\u2019hui que son comit\u00e9 de surveillance et de suivi (DSMB) ind\u00e9pendant a termin\u00e9 sa premi\u00e8re \u00e9valuation d\u2019efficacit\u00e9 de l\u2019\u00e9tude HERACLES de phase\u00a0II (NCT03359980<\/a>) de sa bioth\u00e9rapie la plus avanc\u00e9e, MaaT013, dans la maladie aigu\u00eb du greffon contre l\u2019h\u00f4te, \u00e0 pr\u00e9dominance gastro-intestinale, r\u00e9sistante aux st\u00e9ro\u00efdes (GVHa GI RS) apr\u00e8s allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (allo-GCSH). Le DSMB a confirm\u00e9 l\u2019absence de probl\u00e8mes de s\u00e9curit\u00e9 au cours de l\u2019essai depuis le d\u00e9but jusqu\u2019\u00e0 la premi\u00e8re \u00e9tape d\u2019\u00e9valuation de la s\u00e9curit\u00e9 portant sur cinq patients trait\u00e9s. Le recrutement se d\u00e9roule comme pr\u00e9vu dans des centres en France et en Pologne. Il est pr\u00e9vu que d\u2019autres centres commencent \u00e0 recruter d\u00e9but\u00a02019 dans trois autres pays europ\u00e9ens. MaaT013 est le premier produit bioth\u00e9rapeutique \u00e0 \u00e9cosyst\u00e8me complet et pr\u00eat \u00e0 l\u2019emploi issu de la plateforme Microbiome Restoration Biotherapeutic (MMRB) de MaaT Pharma. Il a en effet re\u00e7u la d\u00e9signation de m\u00e9dicament orphelin de la Food and Drug Administration (FDA) et de l\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA).[\/vc_column_text][nectar_single_testimonial testimonial_style=\u00a0\u00bbsmall_modern\u00a0\u00bb color=\u00a0\u00bbExtra-Color-2″ quote=\u00a0\u00bb\u00ab La premi\u00e8re \u00e9valuation du DSMB confirme nos observations sur l\u2019excellent profil de s\u00e9curit\u00e9 du MaaT013 jusqu\u2019\u00e0 pr\u00e9sent, ce qui est primordial pour ces patients s\u00e9v\u00e8rement malades \u00bb\u00a0\u00bb name=\u00a0\u00bba comment\u00e9 Dr. Ronald Carter,\u00a0\u00bb subtitle=\u00a0\u00bbDirecteur M\u00e9dical de MaaT Pharma.\u00a0\u00bb][nectar_single_testimonial testimonial_style=\u00a0\u00bbsmall_modern\u00a0\u00bb color=\u00a0\u00bbExtra-Color-2″ quote=\u00a0\u00bb\u00ab Apr\u00e8s l\u2019\u00e9chec du traitement par st\u00e9ro\u00efdes, il n\u2019existe actuellement pas de traitement de deuxi\u00e8me ligne autoris\u00e9 pour la aGvH GI RS ; par cons\u00e9quent il est n\u00e9cessaire de pouvoir proposer, contre cette maladie mena\u00e7ant le pronostic vital, de nouvelles options th\u00e9rapeutiques qui ne pr\u00e9sentent pas de risques d\u2019\u00e9v\u00e9nements ind\u00e9sirables s\u00e9rieux susceptibles de compromettre la sant\u00e9 et la survie du patient \u00bb,<\/p>\n

\u00ab Les patients pr\u00e9sentant une aGvH ont un \u00e9cosyst\u00e8me microbien fortement compromis, ce qui a une influence d\u00e9montr\u00e9e sur la survie globale du patient. L\u2019objectif de MaaT013 est de restaurer un microbiote intestinal fonctionnel et de r\u00e9tablir le dialogue bact\u00e9ries-h\u00f4te ainsi que l\u2019hom\u00e9ostasie du syst\u00e8me immunitaire, ce qui constitue une nouvelle voie th\u00e9rapeutique tr\u00e8s prometteuse. \u00bb\u00a0\u00bb name=\u00a0\u00bba ajout\u00e9 le Professeur Mohamad Mohty,\u00a0\u00bb subtitle=\u00a0\u00bbMD, PhD, coordinateur international de l\u2019\u00e9tude HERACLES, professeur d\u2019h\u00e9matologie \u00e0 la Sorbonne et chef du service d\u2019h\u00e9matologie et th\u00e9rapie cellulaire de l\u2019h\u00f4pital Saint Antoine \u00e0 Paris.\u00a0\u00bb][vc_column_text]L\u2019\u00e9tude HERACLES est une \u00e9tude multicentrique \u00e0 bras unique, recrutant 32\u00a0patients pour \u00e9valuer la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 du candidat-m\u00e9dicament de pointe MaaT013 propos\u00e9 par Maat Pharma et visant \u00e0 restaurer le microbiote chez des patients pr\u00e9sentant une aGvH r\u00e9sistant aux st\u00e9ro\u00efdes. L\u2019aGvH aigu\u00eb est un syndrome grave, souvent fatal, impliquant g\u00e9n\u00e9ralement les intestins, la peau et le foie. Jusqu\u2019\u00e0 pr\u00e9sent, les traitements se concentraient largement sur la suppression de la r\u00e9action immunitaire dirig\u00e9e contre l\u2019h\u00f4te induite par les cellules de donneur provenant de la greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques. \u00a0Cependant, ces traitements sont rest\u00e9s cliniquement sans succ\u00e8s dans la plupart des cas, avec des taux de mortalit\u00e9 d\u2019environ 80\u00a0% apr\u00e8s 12\u00a0mois dans les cas r\u00e9sistant aux st\u00e9ro\u00efdes. Avant de recevoir une greffe de cellules souches, les patients d\u00e9veloppant une aGvH sont trait\u00e9s avec une chimioth\u00e9rapie et des antibiotiques intensifs, connus pour affecter gravement la composition du microbiote intestinal.[\/vc_column_text][nectar_single_testimonial testimonial_style=\u00a0\u00bbsmall_modern\u00a0\u00bb color=\u00a0\u00bbExtra-Color-2″ quote=\u00a0\u00bb\u00ab MaaT013 repr\u00e9sente une approche tr\u00e8s diff\u00e9renci\u00e9e visant \u00e0 am\u00e9liorer les r\u00e9sultats des patients pr\u00e9sentant une aGvH et nous croyons fermement, sur la base de nos donn\u00e9es scientifiques et des donn\u00e9es scientifiques externes qui s\u2019accumulent, que les th\u00e9rapies de restauration du microbiome peuvent avoir une influence significative dans les indications oncologiques \u00bb.<\/p>\n

\u00ab Nous avons h\u00e2te d\u2019approfondir nos connaissances sur MaaT013 dans le cadre de cette \u00e9tude europ\u00e9enne, tout en travaillant sur l\u2019extension de cet essai \u00e0 d\u2019autres r\u00e9gions pour en faire b\u00e9n\u00e9ficier les patients \u00e0 l\u2019\u00e9chelle mondiale. \u00bb\u00a0\u00bb name=\u00a0\u00bba d\u00e9clar\u00e9 Herv\u00e9 Affagard,\u00a0\u00bb subtitle=\u00a0\u00bbco-fondateur et CEO de MaaT Pharma\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″ background_hover_color_opacity=\u00a0\u00bb1″ 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″ width=\u00a0\u00bb1\/6″ 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″ 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″ background_hover_color_opacity=\u00a0\u00bb1″ 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″ width=\u00a0\u00bb1\/1″ 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][nectar_highlighted_text color_type=\u00a0\u00bbregular\u00a0\u00bb highlight_color=\u00a0\u00bb#e9a017″ style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n

A propos de MaaT013<\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT013<\/strong> est une bioth\u00e9rapie qui vise \u00e0 restaurer l’\u00e9cosyst\u00e8me du microbiote pour normaliser la r\u00e9ponse immunitaire du patient. MaaT013 est caract\u00e9ris\u00e9 par une grande richesse et une grande diversit\u00e9 microbienne. C\u2019est un produit standardis\u00e9, compos\u00e9 d\u2019une combinaison de microbiotes f\u00e9caux issus de donneurs, pour une administration par lavement. MaaT013<\/strong> vis \u00e0 restaurer la relation symbiotique entre le microbiote intestinal du patient et ses cellules immunitaires afin de corriger la r\u00e9activit\u00e9 et restaurer la tol\u00e9rance du syst\u00e8me immunitaire et ainsi r\u00e9duire la GI-aGvHD. MaaT013 a re\u00e7u la d\u00e9signation de m\u00e9dicament orphelin de la Food and Drug Administration (FDA) aux \u00c9tats-Unis et de l’Agence europ\u00e9enne des m\u00e9dicaments (EMA). MaaT013 est \u00e9valu\u00e9 dans un essai clinique de phase 2 (HERACLES – NCT03359980) et est \u00e9galement administr\u00e9 en usage compassionnel et dans le cadre d\u2019une ATU nominative en France.[\/vc_column_text][nectar_highlighted_text color_type=\u00a0\u00bbregular\u00a0\u00bb highlight_color=\u00a0\u00bb#e9a017″ style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n

A propos de MaaT Pharma<\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT Pharma<\/strong> 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 maladies graves et s\u00e9v\u00e8res. 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 d\u00e9j\u00e0 r\u00e9alis\u00e9 la preuve de concept de son approche chez des patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb et dans un essai clinique de phase 2 dans la GVH aigu\u00eb.<\/p>\n

Pour soutenir le d\u00e9veloppement de notre portefeuille de produits et son extension \u00e0 des indications plus larges, nous avons construit GutPrint\u00ae, une puissante plateforme de d\u00e9couverte et d\u2019analyse pour 1\/ \u00e9valuer les m\u00e9dicaments candidats, 2\/ d\u00e9terminer de nouvelles cibles th\u00e9rapeutiques et 3\/ identifier des biomarqueurs dans la prise en charge de pathologies impliquant le microbiote.<\/p>\n

Nos th\u00e9rapies restaurant l’\u00e9cosyst\u00e8me du microbiote (Microbiome Ecosystem Therapies) peuvent \u00eatre administr\u00e9es par lavement ou encapsul\u00e9e pour une administration orale. Elles<\/p>\n

sont toutes produites dans le cadre tr\u00e8s standardis\u00e9 d\u2019une fabrication et de contr\u00f4les qualit\u00e9 cGMP4 afin de garantir en toute s\u00e9curit\u00e9 l\u2019acc\u00e8s \u00e0 la diversit\u00e9 et la richesse du microbiome. 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