{"id":4354,"date":"2021-06-28T07:41:43","date_gmt":"2021-06-28T07:41:43","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4354"},"modified":"2023-09-25T13:57:06","modified_gmt":"2023-09-25T13:57:06","slug":"maat-pharma-announces-dsmb-approval-to-proceed-to-cohort-4-out-of-5-in-phase-1b-cimon-trial-testing-capsule-formulation-of-microbiome-ecosystem-therapy","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-announces-dsmb-approval-to-proceed-to-cohort-4-out-of-5-in-phase-1b-cimon-trial-testing-capsule-formulation-of-microbiome-ecosystem-therapy\/","title":{"rendered":"MaaT Pharma annonce l\u2019accord du DSMB pour passer \u00e0 la cohorte 4 sur 5 dans l\u2019essai CIMON de phase Ib  \u00e9valuant sa formulation orale de th\u00e9rapie de restauration de l\u2019\u00e9cosyst\u00e8me microbien intestinal"},"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<ul>\n<li>Le comit\u00e9 de surveillance et de suivi (DSMB) ind\u00e9pendant recommande de continuer l\u2019\u00e9tude comme pr\u00e9vu et de d\u00e9buter l\u2019administration \u00e0 la quatri\u00e8me cohorte de patients<\/li>\n<li>L\u2019essai clinique CIMON \u00e9value MaaT033, la formulation orale (g\u00e9lule) du candidat m\u00e9dicament le plus avanc\u00e9 de la soci\u00e9t\u00e9 (MaaT013), chez des patients atteints de leuc\u00e9mie aigu\u00eb my\u00e9lo\u00efde (LAM), \u00e0 la suite d\u2019une chimioth\u00e9rapie intensive<\/li>\n<li>MaaT033 est un traitement \u00e0 base d\u2019\u00e9cosyst\u00e8me microbien \u00e0 haute richesse et haute diversit\u00e9, standardis\u00e9 et d\u00e9riv\u00e9 de donneurs sains, pour une administration orale<\/li>\n<\/ul>\n[\/vc_column_text][vc_column_text]<strong>Lyon, France, 28\u00a0juin\u00a02021 \u2013<\/strong> <a href=\"https:\/\/maat.swebwp.oci.eu\/fr\/\">MaaT Pharma<\/a>, une entreprise de biotechnologie au stade clinique sp\u00e9cialis\u00e9e dans le d\u00e9veloppement de th\u00e9rapies issues du microbiote, \u00e0 \u00e9cosyst\u00e8me complet, en oncologie, a annonc\u00e9 aujourd\u2019hui que le comit\u00e9 de surveillance et de suivi (DSMB) recommandait de passer, sans modifications, \u00e0 la quatri\u00e8me cohorte de l\u2019essai clinique de phase\u00a0IB, aussi appel\u00e9 CIMON, visant \u00e0 d\u00e9terminer la dose. Le DSMB est un comit\u00e9 ind\u00e9pendant de l\u2019entreprise surveillant les progr\u00e8s de l\u2019essai clinique et \u00e9valuant la s\u00e9curit\u00e9, la tol\u00e9rance et la qualit\u00e9 des donn\u00e9es pendant que l\u2019essai est en cours.<\/p>\n<p><em>\u00ab\u00a0Nous sommes ravis que la troisi\u00e8me cohorte sur cinq de cette importante \u00e9tude avec MaaT033 se soit achev\u00e9e avec succ\u00e8s sans aucun signal de s\u00e9curit\u00e9 rapport\u00e9. Cette \u00e9tude repr\u00e9sente une \u00e9tape tr\u00e8s importante dans la d\u00e9termination de la dose cible de ce produit candidat sous forme de g\u00e9lule orale et nous pr\u00e9voyons de lancer une \u00e9tude pivot de phase\u00a0III l\u2019ann\u00e9e prochaine\u00a0\u00bb, <\/em>a comment\u00e9 le Dr John Weinberg, Directeur M\u00e9dical de MaaT Pharma.<\/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.<\/p>\n<p>L\u2019essai CIMON de Phase IB devrait se terminer fin\u00a02021.[\/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 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. 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