{"id":14219,"date":"2025-01-21T19:02:02","date_gmt":"2025-01-21T17:02:02","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=14219"},"modified":"2025-01-21T19:02:02","modified_gmt":"2025-01-21T17:02:02","slug":"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","status":"publish","type":"post","link":"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\/","title":{"rendered":"21 janvier 2025 : MaaT Pharma annonce le r\u00e9sultat positif du deuxi\u00e8me 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 du deuxi\u00e8me 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 recommand\u00e9 que l&rsquo;essai se poursuive comme pr\u00e9vu et 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, a montr\u00e9 un profil de s\u00e9curit\u00e9 et de tol\u00e9rabilit\u00e9 constant.<\/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, 21 janvier 2025 \u2013 18h00 CET \u2013 <a href=\"https:\/\/maat.swebwp.oci.eu\/\">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,\u00a0<\/span><\/strong>annonce que le DSMB a compl\u00e9t\u00e9 la seconde \u00e9valuation portant sur la s\u00e9curit\u00e9 pour l&rsquo;essai de Phase 2b PHOEBUS, le plus large essai contr\u00f4l\u00e9 randomis\u00e9 \u00e9valuant une th\u00e9rapie issue du microbiote en oncologie \u00e0 ce jour, et a recommand\u00e9 la poursuite de l&rsquo;essai sans modification. Le DSMB, compos\u00e9 de 5 experts ind\u00e9pendants, a proc\u00e9d\u00e9 \u00e0 la revue r\u00e9guli\u00e8re pr\u00e9vue tous les 6 mois, des donn\u00e9es de s\u00e9curit\u00e9 portant sur 59 patients (date limite pour l\u2019analyse de donn\u00e9es au 31 octobre 2024). Le comit\u00e9 a conclu que MaaT033 \u00e9tait bien tol\u00e9r\u00e9 et que le profil de s\u00e9curit\u00e9 \u00e9tait satisfaisant.<\/p>\n<p><em>\u00ab\u00a0Nous sommes ravis de constater que MaaT033 continue de d\u00e9montrer un bon profil de s\u00e9curit\u00e9 et que l\u2019essai progresse conform\u00e9ment \u00e0 nos pr\u00e9visions. Nous sommes \u00e9galement tr\u00e8s satisfaits du recrutement pour notre essai de Phase 2b, avec 80 patients inclus \u00e0 fin d\u00e9cembre 2024 \u00bb,<\/em> <strong>a d\u00e9clar\u00e9 le Docteur Gianfranco Pittari, PhD, Directeur m\u00e9dical de MaaT Pharma<\/strong>.<\/p>\n<p>Le recrutement des patients se poursuit \u00e0 un rythme r\u00e9gulier en France, Allemagne, Belgique, Espagne, Pays-Bas et au Royaume-Uni, avec 54 centres cliniques actifs \u00e0 ce jour. 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 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\u00a0pr\u00e9voit d\u2019inclure 387 patients et devrait atteindre jusqu\u2019\u00e0 56 sites d&rsquo;investigation (<a href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT05762211?term=PHOEBUS&amp;draw=2&amp;rank=1\">NCT05762211<\/a>).<\/p>\n<p>Les prochains jalons incluent la revue r\u00e9guli\u00e8re de la s\u00e9curit\u00e9 par le DSMB pr\u00e9vue tous les 6 mois, ainsi qu\u2019une \u00e9valuation par le DSMB des disparit\u00e9s en termes de mortalit\u00e9 entre les groupes, respectivement apr\u00e8s l\u2019inclusion de 60 patients (attendue au T1 2025) et de 120 patients (attendue au T3 2025), avec un suivi de 90 jours post-Allo-GCSH.<\/p>\n<p>Les donn\u00e9es pr\u00e9c\u00e9dentes issues d\u2019un essai de Phase 1b chez des patients atteints de leuc\u00e9mie my\u00e9lo\u00efde aigu\u00eb (LMA) ou de syndrome my\u00e9lodysplasique \u00e0 haut risque (SMD) ayant re\u00e7u une chimioth\u00e9rapie intensive (annonc\u00e9es en janvier 2022), ainsi que d\u2019un essai de Phase 1 chez des patients atteints de scl\u00e9rose lat\u00e9rale amyotrophique (SLA) (annonc\u00e9es en f\u00e9vrier 2024), confirment \u00e9galement le bon profil de s\u00e9curit\u00e9 et de tol\u00e9rabilit\u00e9 de MaaT033.[\/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]<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>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>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. 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