{"id":4841,"date":"2021-05-25T22:26:55","date_gmt":"2021-05-25T22:26:55","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4841"},"modified":"2023-09-25T13:57:13","modified_gmt":"2023-09-25T13:57:13","slug":"maat-pharma-annonce-la-publication-dans-nature-communications-des-resultats-de-lessai-clinique-odyssee-de-phase-1-2","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-annonce-la-publication-dans-nature-communications-des-resultats-de-lessai-clinique-odyssee-de-phase-1-2\/","title":{"rendered":"MaaT Pharma annonce la publication dans Nature Communications des r\u00e9sultats de l&rsquo;essai clinique ODYSSEE de Phase 1\/2."},"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>L&rsquo;essai de la th\u00e9rapie autologue de restauration du microbiote, MaaT011, a atteint ses objectifs principaux en d\u00e9montrant la restauration de l&rsquo;\u00e9quilibre et de la diversit\u00e9 du microbiote intestinal ainsi que la r\u00e9duction du transport de g\u00e8nes r\u00e9sistants aux antibiotiques.<\/li>\n<li>MaaT011 s&rsquo;est r\u00e9v\u00e9l\u00e9 s\u00fbr apr\u00e8s une chimioth\u00e9rapie chez des patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb.<\/li>\n<li>MaaT011 a constitu\u00e9 la base de l&rsquo;approche th\u00e9rapeutique de l&rsquo;\u00e9cosyst\u00e8me complet de la soci\u00e9t\u00e9, qui s&rsquo;est poursuivie avec les candidats-m\u00e9dicaments MaaT013 (dans la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te) et MaaT033 (dans la leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb).<\/li>\n<\/ul>\n[\/vc_column_text][vc_column_text]<strong>Lyon, France, 25 mai 2021<\/strong> &#8211; <a href=\"https:\/\/maat.swebwp.oci.eu\/\">MaaT Pharma<\/a> a annonc\u00e9 aujourd&rsquo;hui la publication des r\u00e9sultats finaux de son essai clinique de phase 1\/2 ODYSSEE dans la revue Nature Communications. Les donn\u00e9es ont d\u00e9montr\u00e9 que le premier candidat-m\u00e9dicament de la soci\u00e9t\u00e9, MaaT011, un traitement par transfert autologue de microbiote f\u00e9cal, \u00e9tait s\u00fbr et efficace pour restaurer int\u00e9gralement le microbiote intestinal des 20 patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb (LMA) participants \u00e0 l\u2019essai et dont les analyses ont \u00e9t\u00e9 effectu\u00e9es en suivant le protocole. En outre, le traitement MaaT011 a montr\u00e9 des r\u00e9sultats cliniques positifs \u00e0 court et \u00e0 long terme, notamment la r\u00e9duction de l&rsquo;inflammation intestinale et du transport intestinal de g\u00e8nes de r\u00e9sistance aux antibiotiques. Les donn\u00e9es de base de l&rsquo;\u00e9tude avaient d\u00e9j\u00e0 \u00e9t\u00e9 pr\u00e9sent\u00e9es sous forme de poster lors du <a href=\"https:\/\/maat.swebwp.oci.eu\/maat-pharma-presents-positive-phase-1b-2a-study-results-in-acute-myeloid-leukemia-patients-at-the-ash-2018-annual-meeting\/\">60e congr\u00e8s annuel de l&rsquo;American Society of Hematology (ASH)<\/a> en d\u00e9cembre 2018.<\/p>\n<p>Les r\u00e9sultats du suivi de l&rsquo;essai ont \u00e9galement montr\u00e9 que seuls 17% (3\/18) des patients atteints de LMA ayant \u00e9t\u00e9 trait\u00e9 par MaaT011 et ayant re\u00e7u une allogreffe de cellules souches h\u00e9matopo\u00ef\u00e9tiques (allo-HCT) ont d\u00e9velopp\u00e9 une maladie du greffon contre l&rsquo;h\u00f4te (GI-GvHD), une complication grave entra\u00eenant souvent des taux \u00e9lev\u00e9s de morbidit\u00e9 et de mortalit\u00e9 pouvant atteindre 80%, ce qui sugg\u00e8re un effet protecteur potentiel \u00e0 long terme de MaaT011 chez ces patients. Le taux de survie globale (OS) dans l&rsquo;essai \u00e9tait de 92% \u00e0 six mois et de 72% \u00e0 deux ans, une comparaison positive par rapport aux \u00e9tudes publi\u00e9es pr\u00e9c\u00e9demment dans lesquelles l&rsquo;OS \u00e0 deux ans variait de 41,9% \u00e0 60% dans ce contexte<sup><a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a><\/sup>.<\/p>\n<p><em>\u00ab\u00a0La publication de nos donn\u00e9es, \u00e9valu\u00e9es par des pairs dans cette revue renomm\u00e9e, est une validation de la rigueur scientifique suivie par MaaT Pharma dans son approche de restauration du microbiote \u00e0- \u00e9cosyst\u00e8me complet. Les donn\u00e9es initiales positives de l&rsquo;\u00e9tude ODYSSEE ont ouvert la voie \u00e0 nos candidats-m\u00e9dicaments MaaT013 et MaaT033, respectivement en administration par lavement et en capsule), qui sont issus de la collecte de microbiote intestinal de donneurs sains. Les r\u00e9sultats complets de l&rsquo;\u00e9tude soutiennent notre hypoth\u00e8se selon laquelle une th\u00e9rapie du microbiote d\u00e9di\u00e9e \u00e0 l\u2019\u00e9cosyst\u00e8me complet et capable de restaurer la haute diversit\u00e9 et la richesse du microbiote intestinal, peut avoir un impact positif pour les patients atteints de tumeurs liquides, y compris \u00e9ventuellement dans un cadre prophylactique\u00a0\u00bb, <\/em>a comment\u00e9 Docteur John Weinberg, directeur m\u00e9dical de MaaT Pharma.<em> \u00ab\u00a0Nous avons r\u00e9cemment annonc\u00e9 des r\u00e9sultats positifs pour MaaT013 dans le cadre de notre essai clinique de phase 2 HERACLES dans la maladie du greffon contre l&rsquo;h\u00f4te et notre formulation orale, MaaT033, est actuellement \u00e9valu\u00e9e dans le cadre d&rsquo;une \u00e9tude clinique de phase 1b chez des patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb ; nous pr\u00e9voyons de terminer cet essai au quatri\u00e8me trimestre de cette ann\u00e9e.\u00a0\u00bb<\/em><\/p>\n<p>Le sch\u00e9ma th\u00e9rapeutique standard pour la LMA repose sur une chimioth\u00e9rapie de premi\u00e8re phase intensive et un traitement par antibiotiques, dont il a \u00e9t\u00e9 d\u00e9montr\u00e9 qu&rsquo;ils alt\u00e8rent consid\u00e9rablement la composition microbiome intestinal en termes de richesse et de diversit\u00e9. En cons\u00e9quence, les interactions h\u00f4te-microbiote peuvent \u00eatre perturb\u00e9es, ce qui entra\u00eene des conditions pathologiques, notamment des r\u00e9ponses immunitaires locales incontr\u00f4l\u00e9es, une inflammation syst\u00e9mique et une incidence accrue de comorbidit\u00e9s et de complications. L&rsquo;\u00e9tude a d\u00e9montr\u00e9 que le traitement par MaaT011 a permis la restauration d\u2019un microbiote intestinal alt\u00e9r\u00e9 \u00e0 un niveau de r\u00e9f\u00e9rence en termes qualitatifs et quantitatifs. En outre, il a permis de r\u00e9duire consid\u00e9rablement les bact\u00e9ries pro-inflammatoires, dont il a \u00e9t\u00e9 prouv\u00e9 qu&rsquo;elles sont pr\u00e9dominantes dans le microbiote apr\u00e8s une chimioth\u00e9rapie intensive.<\/p>\n<p>Professeur Mohamad Mohty, PhD, professeur d&rsquo;h\u00e9matologie \u00e0 l&rsquo;Universit\u00e9 de la Sorbonne et chef du service d&rsquo;h\u00e9matologie et de th\u00e9rapie cellulaire \u00e0 l&rsquo;h\u00f4pital Saint-Antoine \u00e0 Paris, et auteur r\u00e9f\u00e9rant de l&rsquo;article, a ajout\u00e9 : <em>\u00ab\u00a0Les r\u00e9sultats de l&rsquo;\u00e9tude ODYSSEE sont structurants puisqu\u2019ils sugg\u00e8rent que la restauration d&rsquo;un \u00e9cosyst\u00e8me fonctionnel du microbiome intestinal chez les patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb lourdement pr\u00e9trait\u00e9s peut am\u00e9liorer leurs pronostics. Il est \u00e9galement int\u00e9ressant de constater que le traitement par MaaT011 pourrait probablement r\u00e9duire le risque de GvHD chez les patients ayant re\u00e7u une greffe de cellules souches par rapport aux attentes standard dans cette population.\u00a0\u00bb<\/em><\/p>\n<p>L&rsquo;article intitul\u00e9 \u00ab\u00a0Restoration of gut microbiota diversity with autologous fecal microbiota transfer in acute myeloid leukemia patients\u00a0\u00bb r\u00e9sume les r\u00e9sultats de l&rsquo;essai ODYSSEE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02928523?term=NCT02928523&amp;draw=2&amp;rank=1\">NCT02928523<\/a>), un essai interventionnel de phase 1\/2, multicentrique, prospectif et \u00e0 un seul bras, men\u00e9 aupr\u00e8s de patients hospitalis\u00e9s atteints de LMA ou de syndrome my\u00e9lodysplasique (SMD) \u00e0 haut risque. Au total, 25 patients ont \u00e9t\u00e9 trait\u00e9s par MaaT011 et les r\u00e9sultats d&rsquo;efficacit\u00e9 publi\u00e9s concernent les 20 patients int\u00e9grant le profil d&rsquo;analyse en per-protocole.<\/p>\n<p>La publication dans <i>Nature Communications<\/i> est disponible <a href=\"https:\/\/www.nature.com\/articles\/s41467-021-23376-6\">en ligne<\/a>.[\/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 la Leuc\u00e9mie My\u00e9lo\u00efde Aigu\u00eb<\/strong><\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]La leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb (LMA) est un cancer rare et agressif des cellules my\u00e9lo\u00efdes &#8211; des cellules immunitaires qui combattent les infections bact\u00e9riennes, d\u00e9fendent l&rsquo;organisme contre les parasites et emp\u00eachent la propagation des l\u00e9sions tissulaires. Ce cancer progresse rapidement et de mani\u00e8re agressive, il n\u00e9cessite g\u00e9n\u00e9ralement un traitement imm\u00e9diat. Le risque de d\u00e9velopper une LMA augmente avec l&rsquo;\u00e2ge ; elle est plus fr\u00e9quente chez les personnes \u00e2g\u00e9es de plus de 75 ans.[\/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 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<p>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<p>Nos th\u00e9rapies restaurant l&rsquo;\u00e9cosyst\u00e8me du microbiote (<em>Microbiome Ecosystem Therapies<\/em>) 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 microbiote. MaaT Pharma b\u00e9n\u00e9ficie de l&rsquo;engagement 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.<\/p>\n<p>Pour en savoir plus, rendez-nous visite sur <a href=\"https:\/\/maat.swebwp.oci.eu\">www.maatpharma.com<\/a>[\/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 MaaT011<\/strong><\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT011 est un produit de transfert de microbiote f\u00e9cal autologue \u00e0 \u00e9cosyst\u00e8me complet, fabriqu\u00e9 dans des conditions cGMP. Il a \u00e9t\u00e9 \u00e9valu\u00e9 dans le cadre de l&rsquo;\u00e9tude clinique ODYSSEE et repr\u00e9sente la preuve de concept de l\u2019approche th\u00e9rapeutique de MaaT Pharma bas\u00e9e sur la restauration de l\u2019\u00e9cosyst\u00e8me complet du microbiote dans les maladies graves. L&rsquo;\u00e9tude a d\u00e9montr\u00e9 que la r\u00e9introduction du propre microbiote du patient apr\u00e8s la chimioth\u00e9rapie peut restaurer le microbiote intestinal et avoir un impact b\u00e9n\u00e9fique chez les patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb. MaaT011 a ainsi constitu\u00e9 la base de l&rsquo;approche th\u00e9rapeutique de restauration de l&rsquo;\u00e9cosyst\u00e8me complet de la soci\u00e9t\u00e9, qui se poursuit avec les candidats-m\u00e9dicaments MaaT013 (lavement) et MaaT033 (formulation orale), qui sont des produits de bioth\u00e9rapies issues du microbiote standardis\u00e9s, d\u00e9di\u00e9s \u00e0 la restauration de l&rsquo;\u00e9cosyst\u00e8me complet, pr\u00eats \u00e0 l&#8217;emploi, \u00e0 haute richesse et \u00e9labor\u00e9s \u00e0 partir de dons. Des donn\u00e9es pr\u00e9liminaires positives pour MaaT013 dans le traitement de la maladie aigu\u00eb du greffon contre l&rsquo;h\u00f4te ont \u00e9t\u00e9 r\u00e9cemment <a href=\"https:\/\/maat.swebwp.oci.eu\/maat-pharma-announces-positive-topline-results-from-phase-2-heracles-clinical-trial-with-lead-microbiome-ecosystem-therapy-maat013-in-patients-with-acute-graft-versus-host-disease\/\">annonc\u00e9es<\/a>. 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