{"id":36849,"date":"2020-08-25T09:00:00","date_gmt":"2020-08-25T07:00:00","guid":{"rendered":"https:\/\/www.ipsen.com\/?post_type=press_release&#038;p=36849"},"modified":"2023-09-06T16:38:14","modified_gmt":"2023-09-06T14:38:14","slug":"ipsen-presentera-les-resultats-de-move-le-premier-essai-mondial-de-phase-iii-sur-la-fibrodysplasie-ossifiante-progressive-fop-lors-de-la-reunion-annuelle-2020-de-lasbmr","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/fr\/press-releases\/ipsen-presentera-les-resultats-de-move-le-premier-essai-mondial-de-phase-iii-sur-la-fibrodysplasie-ossifiante-progressive-fop-lors-de-la-reunion-annuelle-2020-de-lasbmr\/","title":{"rendered":"Ipsen pr\u00e9sentera les r\u00e9sultats de MOVE, le premier essai mondial de Phase III sur la fibrodysplasie ossifiante progressive (FOP), lors de la r\u00e9union annuelle 2020 de l\u2019ASBMR"},"content":{"rendered":"<p><em>Ce communiqu\u00e9 de presse a \u00e9t\u00e9 approuv\u00e9 par l\u2019ASBMR pour diffusion le 25 ao\u00fbt<\/em><\/p>\n<ul>\n<li style=\"margin-bottom:3px\">Les analyses post-hoc ont d\u00e9montr\u00e9 une r\u00e9duction substantielle (62 %) du volume annualis\u00e9 moyen de nouvelles ossifications h\u00e9t\u00e9rotopiques chez les patients atteints de fibrodysplasie ossifiante progressive (FOP) qui \u00e9taient trait\u00e9s par le m\u00e9dicament exp\u00e9rimental par voie orale palovarot\u00e8ne1<\/li>\n<li style=\"margin-bottom:3px\">Les r\u00e9sultats de la troisi\u00e8me analyse interm\u00e9diaire de l\u2019essai MOVE, la premi\u00e8re et la seule \u00e9tude de Phase III multicentrique de ce type, comprenant la plus large \u00e9tude interventionnelle sur la FOP \u00e0 ce jour avec 107 participants, sugg\u00e8rent que le palovarot\u00e8ne pourrait offrir une solution th\u00e9rapeutique significative aux patients atteints de FOP1<\/li>\n<\/ul>\n<p><b>PARIS, FRANCE, 25 AO\u00dbT 2020 \u2013 <\/b>Ipsen (Euronext: IPN ; ADR : IPSEY) a annonc\u00e9 aujourd\u2019hui les r\u00e9sultats de l\u2019essai MOVE, la premi\u00e8re et la seule \u00e9tude multicentrique de Phase III sur la fibrodysplasie ossifiante progressive (FOP), qui sera d\u00e9voil\u00e9e dans une pr\u00e9sentation orale lors de l\u2019\u00e9dition 2020 de la r\u00e9union annuelle de l\u2019<em>American Society for Bone and Mineral Research<\/em> (ASBMR), le samedi 12 septembre \u00e0 de 11h \u00e0 12h30 ET. L\u2019administration du palovarot\u00e8ne dans le cadre de l\u2019essai clinique MOVE a \u00e9t\u00e9 interrompue lorsque le crit\u00e8re de futilit\u00e9 a \u00e9t\u00e9 atteint dans le cadre de l\u2019analyse int\u00e9rimaire pr\u00e9vue au protocole. Cependant, des analyses post-hoc ult\u00e9rieures ont r\u00e9v\u00e9l\u00e9 que le palovarot\u00e8ne, un agoniste du r\u00e9cepteur gamma de l\u2019acide r\u00e9tino\u00efque (RAR\u03b3) administr\u00e9 par voie orale actuellement en d\u00e9veloppement clinique, permettait de r\u00e9duire le volume annuel de nouvelles ossifications h\u00e9t\u00e9rotopiques (OH) chez les participants enfants et adultes atteints de FOP. Ces donn\u00e9es ont \u00e9t\u00e9 compar\u00e9es \u00e0 celles de patients non trait\u00e9s d\u2019une \u00e9tude d\u2019histoire naturelle sur 24 mois.1<br \/>\nLes r\u00e9sultats de l\u2019essai MOVE ont d\u00e9montr\u00e9 une r\u00e9duction de 62 % du volume annualis\u00e9 moyen de nouvelles OH chez les participants trait\u00e9s par palovarot\u00e8ne (8 821 mm3) (n = 97) par rapport aux patients non trait\u00e9s (23 318 mm3) (n = 98) (valeur-p est. du mod\u00e8le lin\u00e9aire \u00e0 effets mixtes pond\u00e9r\u00e9s par le nominal [wLME] pour -11 611 mm3 = 0,0292). Une fermeture pr\u00e9matur\u00e9e du cartilage de croissance (n = 18) ou un trouble \u00e9piphysaire (n = 1) a \u00e9t\u00e9 observ\u00e9 chez 27,1% (19\/70) des participants qui pr\u00e9sentaient un squelette immature \u00e0 l\u2019inclusion.1 Les donn\u00e9es de tol\u00e9rance du palovarot\u00e8ne \u00e9taient par ailleurs g\u00e9n\u00e9ralement coh\u00e9rentes avec les effets ind\u00e9sirables connus des r\u00e9tino\u00efdes.<br \/>\nLa FOP est une maladie g\u00e9n\u00e9tique ultra-rare qui affecte environ 1,36 personne par million de vies dans le monde2,3. Cette pathologie se caract\u00e9rise par la formation d\u2019os dans les tissus mous et conjonctifs, connue sous le nom d\u2019ossification h\u00e9t\u00e9rotopique (OH)4. Des \u00e9pisodes sporadiques de gonflement douloureux des tissus mous, appel\u00e9s \u00ab pouss\u00e9es \u00bb, peuvent pr\u00e9c\u00e9der les OH3. Les OH sont permanentes et entra\u00eenent de graves limitations fonctionnelles de l\u2019amplitude articulaire, une invalidit\u00e9 progressive et cumulative et une diminution de l\u2019esp\u00e9rance de vie. Il n\u2019existe \u00e0 ce jour aucun traitement approuv\u00e9 pour r\u00e9duire ou pr\u00e9venir la formation osseuse h\u00e9t\u00e9rotopique dans la FOP4.<br \/>\n\u00ab <em>Les pouss\u00e9es cumulatives d\u2019ossification h\u00e9t\u00e9rotopique dans tout le corps sont la principale caract\u00e9ristique de la FOP. Elles limitent gravement les capacit\u00e9s physiques du patient au fil du temps<\/em>,\u00bb a d\u00e9clar\u00e9 le Dr Robert Pignolo, M.D., Ph.D., Division de m\u00e9decine g\u00e9riatrique et de g\u00e9rontologie, D\u00e9partement de m\u00e9decine interne, clinique Mayo. \u00ab <em>L\u2019essai MOVE apporte des informations essentielles pour \u00e9laborer des strat\u00e9gies de traitement tant attendues. Il a d\u00e9montr\u00e9 que le traitement oral par palovarot\u00e8ne peut r\u00e9duire le volume de nouvelles OH, ce qui repr\u00e9sente une option th\u00e9rapeutique significative dans la FOP, en particulier chez les enfants plus \u00e2g\u00e9s et les adultes. <\/em>\u00bb<br \/>\n\u00ab <em>Nous sommes heureux de pr\u00e9senter les r\u00e9sultats de la troisi\u00e8me analyse interm\u00e9diaire de l\u2019essai de Phase III MOVE sur la FOP \u00e9valuant le palovarot\u00e8ne, m\u00e9dicament exp\u00e9rimental par voie orale d\u2019Ipsen, \u00e0 la communaut\u00e9 internationale lors de la r\u00e9union annuelle de l\u2019ASBMR, <\/em>\u00bb a comment\u00e9 Jim Roach, MD, Vice-Pr\u00e9sident Senior, Responsable global de l\u2019Aire th\u00e9rapeutique d\u00e9di\u00e9e aux maladies rares chez Ipsen. \u00ab <em>Compte tenu des premiers \u00e9changes avec la FDA, l\u2019intention d\u2019Ipsen est d\u2019avancer pour soumettre une demande d\u2019enregistrement aupr\u00e8s des autorit\u00e9s am\u00e9ricaines. Concernant le march\u00e9 europ\u00e9en, les discussions avec l\u2019EMA sont en cours<\/em>. <em>Nous poursuivons nos efforts aupr\u00e8s des autorit\u00e9s r\u00e8glementaires et sommes ravis d\u2019avoir fait un pas de plus vers notre objectif d\u2019apporter aussi t\u00f4t que possible cette solution de traitement potentielle aux personnes atteintes de FOP. <\/em>\u00bb<br \/>\n\u00ab <em>Les personnes atteintes de FOP voient parfois leur vie menac\u00e9e et les options de traitement restent aujourd\u2019hui limit\u00e9es.<\/em> <em>Nous sommes encourag\u00e9s par les nouvelles donn\u00e9es de l\u2019essai MOVE qui d\u00e9montrent une r\u00e9duction du volume d\u2019OH, et esp\u00e9rons que cette \u00e9tude permettra \u00e0 terme d\u2019offrir une solution th\u00e9rapeutique viable \u00e0 la communaut\u00e9 FOP,<\/em> \u00bb a d\u00e9clar\u00e9 Adam Sherman, repr\u00e9sentant de l\u2019<em>International Fibrodysplasia Ossificans Progressiva Association<\/em> (IFOPA).<br \/>\nL\u2019essai MOVE (NCT03312634) est une \u00e9tude en cours de Phase III, multicentrique et ouverte, men\u00e9e aupr\u00e8s de 107 patients atteints de FOP qui ont re\u00e7u le palovarot\u00e8ne par voie oral comme traitement chronique (5 mg une fois par jour) et \u00e9pisodique (20 mg une fois par jour pendant 4 semaines, suivi de 10 mg pendant \u2265 8 semaines pour les pouss\u00e9es et les traumatismes). L\u2019essai MOVE a pour principaux objectifs d\u2019\u00e9valuer l\u2019efficacit\u00e9 du palovarot\u00e8ne dans la r\u00e9duction du volume de nouvelles OH chez les patients atteints de FOP diagnostiqu\u00e9s par tomodensitom\u00e9trie corps entier \u00e0 faible dose (t\u00eate exclue) par rapport aux patients non trait\u00e9s de l\u2019\u00e9tude mondiale d\u2019histoire naturelle sur la FOP d\u2019Ipsen (NHS; NCT02322255) ; et d\u2019\u00e9valuer l\u2019innocuit\u00e9 du palovarot\u00e8ne chez les patients adultes et enfants atteints de FOP.5 L\u2019\u00e9tude NHS est la premi\u00e8re \u00e9tude du genre \u00e9valuant la progression de la FOP. En juin dernier, dans le cadre de son engagement continu envers les maladies rares, Ipsen a pr\u00e9sent\u00e9 8 abstracts dans le <em>Journal of Endocrine Society<\/em>. Ipsen a notamment pr\u00e9sent\u00e9 un abstract mettant en \u00e9vidence des donn\u00e9es de 12 mois mesurant la progression naturelle de la FOP et l\u2019impact des OH sur les capacit\u00e9s physiques des patients au fil du temps, provenant de l\u2019\u00e9tude NHS.6<br \/>\n\u00c0 la date limite de collecte des donn\u00e9es, tous les participants \u00e0 l\u2019essai avaient signal\u00e9 \u2265 1 effet ind\u00e9sirable li\u00e9 au traitement ; 97,0 % ont signal\u00e9 \u2265 1 effet ind\u00e9sirable li\u00e9 au traitement associ\u00e9 aux r\u00e9tino\u00efdes (par ex. : effets mucocutan\u00e9s). Le plus haut degr\u00e9 de gravit\u00e9 des effets ind\u00e9sirables \u00e9tait l\u00e9ger chez 32,2 % des participants, mod\u00e9r\u00e9 chez 45,5 % et s\u00e9v\u00e8re chez 22,2 % d\u2019entre eux. Une fermeture pr\u00e9matur\u00e9e du cartilage de croissance (n = 18) ou un trouble \u00e9piphysaire (n = 1) ont \u00e9t\u00e9 observ\u00e9s chez 27,1 % (19\/70) des participants qui pr\u00e9sentaient un squelette immature \u00e0 l\u2019inclusion.1 Les r\u00e9sultats de l\u2019essai ont d\u00e9montr\u00e9 une r\u00e9duction de 62 % du volume annualis\u00e9 moyen de nouvelles OH chez les participants ayant re\u00e7u palovarot\u00e8ne (8 821 mm3) par rapport aux patients non trait\u00e9s (23 318 mm3) (valeur p du mod\u00e8le wLME = 0,0292). Les donn\u00e9es pr\u00e9sent\u00e9es le 12 septembre proviennent de la troisi\u00e8me analyse interm\u00e9diaire (IA3) de l\u2019essai MOVE.<br \/>\n<b><u>Pour plus d\u2019informations :<\/u><\/b><\/p>\n<table style=\"border-collapse: collapse;width:731px;border-collapse:collapse\">\n<tr>\n<td style=\"width:252px\"><\/td>\n<td style=\"width:277px\"><\/td>\n<td colspan=\"2\" style=\"width:161.5px\"><\/td>\n<\/tr>\n<tr>\n<td style=\"width:252px\"><b>M\u00e9dias<\/b><br \/>\nJess Smith<br \/>\nDirecteur Senior, Communication Globale Franchise<br \/>\n+44 (0)7557 267634<br \/>\n<a href=\"mailto:jess.smith@ipsen.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>jess.smith@ipsen.com<\/b><\/a><\/p>\n<p><b>Communaut\u00e9 financi\u00e8re<\/b><br \/>\nEugenia Litz<br \/>\nVice-Pr\u00e9sident, Relations Investisseurs<br \/>\n+44 (0) 1753 627721<br \/>\n<a href=\"mailto:eugenia.litz@ipsen.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>eugenia.litz@ipsen.com<\/b><\/a><\/td>\n<td colspan=\"2\" style=\"width:417.5px\">Maryann Quinn<br \/>\nDirecteur, Communication Produit<br \/>\nAm\u00e9rique du Nord<br \/>\n1-857-529-1151<br \/>\nMaryann.quinn@ipsen.com<\/p>\n<p>Myriam Koutchinsky<br \/>\nInvestor Relations Manager<br \/>\n+33 (0)1 58 33 51 04<br \/>\n<a href=\"mailto:myriam.koutchinsky@ipsen.com\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>myriam.koutchinsky@ipsen.com<\/b><\/a><\/td>\n<td style=\"width:21px\"><\/td>\n<\/tr>\n<\/table>\n<p><b>R\u00e9f\u00e9rences<\/b><\/p>\n<ol>\n<li style=\"margin-bottom:3px\">Pignolo R et al. Palovarotene (PVO) for fibrodysplasia ossificans progressiva (FOP): Data from the phase III MOVE trial. ASBMR September 2020.<\/li>\n<li style=\"margin-bottom:3px\">Lilijesthrom M &amp; Bogard B. The Global Known FOP Population. Presented at the FOP Drug Development Forum. Boston, MA; 2016.<\/li>\n<li style=\"margin-bottom:3px\">Baujat et al. Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a record linkage of two national databases. <em>Orphanet Journal of Rare Diseases.<\/em> 2017; 12:123.<\/li>\n<li style=\"margin-bottom:3px\">The Medical Management of Fibrodysplasia Ossificans Progressiva: Current Treatment Considerations, IFOPA. Derni\u00e8re mise \u00e0 jour : mai 2020. Disponible \u00e0 l\u2019adresse : <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=CrG3ox0d8vSVNQdvj7HR71b5WFneDjtVr3pXsW7HZ8bAftU5Avy7S_OWMIQQmlMN3g9UYnbBqTl924riOTSOpSDbadOXlOa7Qg1koZA5-3BDSxL4KQCAHK9QN26BMd15zUWCFdfe6s3AAxxSx0okR1kXU7vfnpwJAIzlKQzsf8aj413ojlBDV_dckHj0tCZgwoSR1n-7S_WEVWt7Id-zjd6rt8PkAzVUE7H7ITAv0UUFnAmYZHhjJVm47UB7fpZA\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>http:\/\/fundacionfop.org.ar\/wp-content\/uploads\/2019\/05\/GUIDELINES-May-2019.pdf<\/b><\/a><\/li>\n<li style=\"margin-bottom:3px\">gov. Derni\u00e8re mise \u00e0 jour : ao\u00fbt 2020 Disponible \u00e0 l\u2019adresse : <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=CrG3ox0d8vSVNQdvj7HR7zhAK-xjy8n6FQaine9dSaaPzRg2IEF7fzteTncrFGiCf4omqjwMlhxMWHTwpymfgNdYefWAjD1bzV3CMqfrZQRTH_cPjrtWkr2fW2XZFbyAwnO-T6p2A6Dpf4ZfaH9CGdeOqK7rYCaqFrDNaxfRZBg=\" rel=\"nofollow noopener\" target=\"_blank\" title=\"\"><b>https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03312634<\/b><\/a><\/li>\n<li style=\"margin-bottom:3px\">Al Mukaddam M et al. A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP): 12-Month Outcomes. J Endocr Soc. 2020;4 (Supplement 1):OR29-05<\/li>\n<\/ol>\n<p id=\"gnw_attachments_section-header\"> <strong>Pi\u00e8ce jointe<\/strong><\/p>\n<ul id=\"gnw_attachments_section-items\">\n<li> <a target=\"_blank\" href=\"https:\/\/www.globenewswire.com\/Tracker?data=LXGBIkBzzU5_Jd3V6t-J1ZqODJwEtjRM_r3nqp-LEdZ0nNXwbtkMpQRgoKl56WcJbVuvhTClwHH6lJBckFFNUkKQ-Sv2shGlFxtkNjnM0RKAnyUH2ckeRy5e_FplEymU9PMjoZVLy5pvK9VlbMdsmFkXAnGBJ-PE-h_PBPJ4WNzwJfYmsbps4UGj47qo355R\" title=\"Ipsen-MOVE-25-Aout-2020\" rel=\"nofollow noopener\">Ipsen-MOVE-25-Aout-2020<\/a><\/li>\n<\/ul>\n<p><img src='https:\/\/ml-eu.globenewswire.com\/media\/MzRkZGJjNTAtNzdiMi00ZGEwLWE1ZDAtMmE3OWQ3ZmM2Mzk1LTEwMTA5NDM=\/tiny\/Ipsen-SA.png' \/><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"template":"","categories":[1233,3556,3563],"tags":[],"class_list":["post-36849","press_release","type-press_release","status-publish","hentry","category-pressrelease-fr","category-corporate-pressrelease-fr","category-rare-diseases-pressrelease-fr","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Ipsen pr\u00e9sentera les r\u00e9sultats de MOVE, le premier essai mondial de Phase III sur la fibrodysplasie ossifiante progressive (FOP), lors de la r\u00e9union annuelle 2020 de l\u2019ASBMR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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