{"id":4377,"date":"2020-12-22T07:56:50","date_gmt":"2020-12-22T07:56:50","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4377"},"modified":"2023-09-25T13:59:01","modified_gmt":"2023-09-25T13:59:01","slug":"maat-pharma-announces-first-positive-dsmb-safety-review-for-phase-ib-cimon-trial-testing-its-microbiome-ecosystem-therapy-capsule-formulation-in-aml-patients","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-announces-first-positive-dsmb-safety-review-for-phase-ib-cimon-trial-testing-its-microbiome-ecosystem-therapy-capsule-formulation-in-aml-patients\/","title":{"rendered":"MaaT Pharma annonce l\u2019accord du DSMB pour poursuivre l\u2019essai CIMON de phase Ib \u00e9valuant sa formulation orale de th\u00e9rapie de restauration du microbiote chez les patients atteints de LAM"},"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; 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]\n<ul>\n<li>Le comit\u00e9 de surveillance et de suivi (DSMB) ind\u00e9pendant recommande la poursuite de l\u2019\u00e9tude CIMON et le d\u00e9but de l\u2019administration \u00e0 la seconde cohorte de patients<\/li>\n<li>L\u2019\u00e9tude \u00e9value la s\u00e9curit\u00e9, le dosage et l\u2019activit\u00e9 de MaaT033 chez des patients atteints de leuc\u00e9mie aigu\u00eb my\u00e9lo\u00efde recevant une chimioth\u00e9rapie intensive<\/li>\n<\/ul>\n[\/vc_column_text][vc_column_text]<strong>Lyon, France, 22\u00a0d\u00e9cembre\u00a02020 \u2013<\/strong> <a href=\"https:\/\/maat.swebwp.oci.eu\/\">MaaT Pharma<\/a> a annonc\u00e9 aujourd\u2019hui qu\u2019un comit\u00e9 de surveillance et de suivi (DSMB) ind\u00e9pendant a termin\u00e9 sa premi\u00e8re analyse de l\u2019essai clinique de phase\u00a0Ib en cours, CIMON, avec MaaT033, la formulation orale, du candidat-m\u00e9dicament le plus avanc\u00e9 de l\u2019entreprise, MaaT013, d\u00e9di\u00e9 aux patients atteints de leuc\u00e9mie aigu\u00eb my\u00e9lo\u00efde (LAM) ou de syndrome my\u00e9lodysplasique (SMD) ayant re\u00e7u une chimioth\u00e9rapie intensive. Le DSMB a \u00e9valu\u00e9 les donn\u00e9es de s\u00e9curit\u00e9 de la premi\u00e8re cohorte de patients trait\u00e9e avec la premi\u00e8re dose de MaaT033 et a confirm\u00e9 l\u2019absence de probl\u00e8mes de s\u00e9curit\u00e9 pendant l\u2019essai et a recommand\u00e9 que l\u2019essai soit poursuivi sans modifications.<\/p>\n<p>Les \u00e9tudes ont montr\u00e9 que la chimioth\u00e9rapie r\u00e9duit s\u00e9v\u00e8rement les r\u00e9seaux d\u2019esp\u00e8ces microbiennes dans l\u2019intestin conduisant \u00e0 la perturbation de sa couche \u00e9pith\u00e9liale protectrice et de la fonctionnalit\u00e9 du syst\u00e8me immunitaire, affectant n\u00e9gativement les chances de survie des patients. MaaT033, qui se caract\u00e9rise par une grande diversit\u00e9 et richesse des esp\u00e8ces microbiennes, a \u00e9t\u00e9 con\u00e7u pour restaurer un microbiote intestinal fonctionnel et r\u00e9tablir l\u2019hom\u00e9ostase du syst\u00e8me immunitaire afin d\u2019am\u00e9liorer les r\u00e9sultats cliniques avec une prise par voie orale, facile \u00e0 administrer.<\/p>\n<p>\u00ab\u00a0<em>L\u2019\u00e9valuation positive du DSMB soutient nos donn\u00e9es analys\u00e9es \u00e0 date et conforte la s\u00e9curit\u00e9 de nos traitements de restauration du microbiote \u00e0 \u00e9cosyst\u00e8me complet d\u2019\u00e9cosyst\u00e8me au sein de cette population de patients. Nous sommes impatients de poursuivre cet essai avec la prochaine cohorte de patients et de d\u00e9terminer le dosage qui sera utilis\u00e9 dans l\u2019\u00e9tude de phase\u00a0II\u00a0\u00e0 venir\u00a0\u00bb, <\/em>a comment\u00e9 Docteur John Weinberg, Directeur m\u00e9dical chez MaaT Pharma. <em>\u00ab\u00a0Notre objectif est de proposer une formulation pratique permettant une utilisation dans un large groupe de patients et qui compl\u00e8te notre premier candidat-m\u00e9dicament MaaT013.\u00a0\u00bb<\/em><\/p>\n<p>L\u2019essai CIMON (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04150393\">NCT04150393<\/a>) devrait recruter un total de 27\u00a0patients dans 6\u00a0centres en France. Il s\u2019agit d\u2019une \u00e9tude de phase Ib, visant \u00e0 \u00e9valuer la dose tol\u00e9r\u00e9e maximale de MaaT033, sur une dur\u00e9e de 7 ou 14\u00a0jours, dans le but d\u2019obtenir ma meilleure colonisation possible du microbiome intestinal de patients atteints de leuc\u00e9mie aigu\u00eb my\u00e9lo\u00efde (LAM) ou de syndrome my\u00e9lodysplasique \u00e0 haut risque, et recevant une chimioth\u00e9rapie intensive. La s\u00e9curit\u00e9, la tol\u00e9rance et la d\u00e9termination du dosage seront \u00e9valu\u00e9s ainsi que l\u2019impact sur le microbiote intestinal, afin d\u2019identifier la dose recommand\u00e9e pour l\u2019essai de phase\u00a0II. La phase Ib de l\u2019essai CIMON devrait se terminer au quatri\u00e8me trimestre\u00a02021.<\/p>\n<p>Prof. Christian Recher, PU-PH, chef du service d\u2019h\u00e9matologie du CHU de Toulouse, France et coordinateur de l\u2019essai CIMON ajoute : \u00ab\u00a0<em>Les traitements des h\u00e9matopathies malignes telles que la leuc\u00e9mie aigu\u00eb my\u00e9lo\u00efde et le syndrome my\u00e9lodysplasique entra\u00eenent d\u2019importantes modifications n\u00e9gatives du microbiote intestinal des patients. Ces derni\u00e8res diminuent les chances de survie des patients, en augmentant les risques tels que des infections intestinales ou syst\u00e9miques ou une maladie du greffon contre l\u2019h\u00f4te chez des patients qui re\u00e7oivent une greffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques. Par cons\u00e9quent, nous pensons que reconstituer le microbiote avec un traitement microbien riche et hautement diversifi\u00e9 tel que MaaT033 offre une opportunit\u00e9 d\u2019am\u00e9liorer les r\u00e9sultats cliniques pour ces patients.\u00a0\u00bb<\/em>[\/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\/1&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][nectar_highlighted_text color_type=\u00a0\u00bbregular\u00a0\u00bb highlight_color=\u00a0\u00bb#e9a017&Prime; style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n<h3><em><strong>A propos de MaaT033<\/strong><\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT033 est une th\u00e9rapie issue du microbiote pour administration orale, \u00e0 haute richesse et diversit\u00e9 bact\u00e9rienne, \u00e0 \u00e9cosyst\u00e8me complet, standardis\u00e9e, pr\u00eate \u00e0 l\u2019emploi et issue de donneurs sains. Elle est fabriqu\u00e9e dans le centre de production europ\u00e9en de MaaT Pharma r\u00e9pondant aux BPF actuelles. MaaT033 est con\u00e7u pour restaurer l\u2019\u00e9cosyst\u00e8me intestinal \u00e0 sa pleine fonctionnalit\u00e9 afin d\u2019am\u00e9liorer les r\u00e9sultats cliniques et limiter les \u00e9v\u00e9nements ind\u00e9sirables li\u00e9s aux traitements conventionnels des tumeurs liquides. La formulation en g\u00e9lule facilite l\u2019administration tout en maintenant une richesse et une diversit\u00e9 \u00e9lev\u00e9es et constantes des esp\u00e8ces microbiennes, y compris les esp\u00e8ces anti-inflammatoires \u00ab\u00a0Butycore<sup>TM<\/sup>\u00a0\u00bb, qui caract\u00e9risent les th\u00e9rapies microbiote \u00e0 \u00e9cosyst\u00e8me complet de MaaT Pharma.[\/vc_column_text][nectar_highlighted_text color_type=\u00a0\u00bbregular\u00a0\u00bb highlight_color=\u00a0\u00bb#e9a017&Prime; style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n<h3><em><strong>A propos de MaaT Pharma<\/strong><\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]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 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. Pour soutenir le d\u00e9veloppement de son portefeuille de produits et son extension \u00e0 des indications plus larges, MaaT Pharma a d\u00e9velopp\u00e9 GutPrint\u00ae, une puissante plateforme de d\u00e9couverte et d\u2019analyse pour d\u00e9terminer de nouvelles cibles th\u00e9rapeutiques, \u00e9valuer les m\u00e9dicaments candidats et identifier des biomarqueurs dans la prise en charge de pathologies impliquant le microbiote.<\/p>\n<p>Les th\u00e9rapies issues d\u2019un \u00e9cosyst\u00e8me microbien (Microbiome Ecosystem Therapies) d\u00e9velopp\u00e9es par MaaT Pharma peuvent \u00eatre administr\u00e9es par lavement ou encapsul\u00e9e pour une administration orale. Elles 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 la richesse du microbiome. MaaT Pharma b\u00e9n\u00e9ficie de l\u2019engagement de scientifiques de renomm\u00e9e mondiale et de relations \u00e9tablies avec les instances r\u00e9glementaires pour \u00eatre le fer de lance des b\u00e9n\u00e9fices th\u00e9rapeutiques de la modulation du microbiote des patients et de son int\u00e9gration dans la pratique clinique.[\/vc_column_text][\/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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