{"id":5775,"date":"2024-09-12T15:05:02","date_gmt":"2024-09-12T20:05:02","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5775"},"modified":"2025-06-27T11:13:06","modified_gmt":"2025-06-27T16:13:06","slug":"nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-u-s-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2024\/09\/12\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-u-s-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration\/","title":{"rendered":"Nanoscope Therapeutics anuncia una reuni\u00f3n de fin de fase 2 con la FDA de EE. UU. y un plan para iniciar un ensayo cl\u00ednico de fase 3 de MCO-010 para tratar la degeneraci\u00f3n macular de Stargardt"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5775\" class=\"elementor elementor-5775\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b9d610d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b9d610d\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\r\n\t\t\t\t\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fb9e512\" data-id=\"fb9e512\" data-element_type=\"column\" data-e-type=\"column\">\r\n\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\r\n\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7f871d16 elementor-widget elementor-widget-text-editor\" data-id=\"7f871d16\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em><strong>Se prev\u00e9 que el ensayo de registro de fase 3 comience en breve.<\/strong><\/em><\/p><p>DALLAS,\u00a0<span class=\"legendSpanClass\"><span class=\"xn-chron\">12 de septiembre de 2024<\/span><\/span>\u00a0 \u2014 <a href=\"http:\/\/nanostherapeutics.com\/es\/\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscopio Therapeutics Inc.<\/a>, una empresa de biotecnolog\u00eda cl\u00ednica en etapa avanzada que desarrolla terapias gen\u00e9ticas para enfermedades degenerativas de la retina y degeneraci\u00f3n macular relacionada con la edad (DMRE), anunci\u00f3 hoy una productiva reuni\u00f3n de fin de fase 2 (EOP2) con la Administraci\u00f3n de Alimentos y Medicamentos de los EE. UU. (FDA) para su programa cl\u00ednico que eval\u00faa MCO-010 para el tratamiento de la p\u00e9rdida grave de la visi\u00f3n debido a la degeneraci\u00f3n macular de Stargardt (SMD), lo que respalda el avance de MCO-010 a un ensayo de registro de fase 3.<\/p><p>Los resultados clave del debate de la reuni\u00f3n EOP2 incluyeron:<\/p><ul type=\"disc\"><li>La FDA brind\u00f3 informaci\u00f3n clara sobre el ensayo de registro de fase 3 propuesto en pacientes con SMD destinado a respaldar la seguridad y la eficacia de MCO-010. El dise\u00f1o del estudio propuesto consistir\u00e1 en un grupo de dosis intrav\u00edtrea \u00fanica de MCO-010, asignado aleatoriamente 1:1 a una cohorte de control que recibir\u00e1 una inyecci\u00f3n simulada.<\/li><li>La FDA confirm\u00f3 que un cambio en la agudeza visual mejor corregida (MAVC) que emplea pruebas en la tabla ETDRS es apropiado para su uso en un criterio de valoraci\u00f3n de eficacia primario que eval\u00faa el cambio desde el inicio hasta la semana 52 en el ensayo de fase 3 propuesto.<\/li><li>La FDA brind\u00f3 informaci\u00f3n valiosa sobre los m\u00e9todos estad\u00edsticos para los puntos finales primarios y secundarios propuestos que servir\u00e1n para una mayor colaboraci\u00f3n con la FDA para alinearse con los an\u00e1lisis estad\u00edsticos.<\/li><li>La FDA ofreci\u00f3 continuar el debate y brindar asistencia para planificar una evaluaci\u00f3n adicional de la prueba de discriminaci\u00f3n de forma de luminancia m\u00faltiple para respaldar su uso como punto final secundario clave.<\/li><li>Se logr\u00f3 la alineaci\u00f3n en el reclutamiento de pacientes legalmente ciegos con visi\u00f3n peor que 20\/200, y tan j\u00f3venes como de 12 a\u00f1os de edad, para el pr\u00f3ximo estudio, ampliando la poblaci\u00f3n evaluada de la estudiada en la Fase 2.<\/li><li>La FDA acord\u00f3 la suficiencia del paquete no cl\u00ednico actual para respaldar una futura presentaci\u00f3n de BLA.<\/li><\/ul><p>\u201cLos pacientes que sufren de degeneraci\u00f3n macular de Stargardt se enfrentan a una carga de enfermedad sustancial sin que existan tratamientos restauradores disponibles en la actualidad\u201d, dijo\u00a0<span class=\"xn-person\">Sulagna Bhattacharya<\/span>, Cofundador y director ejecutivo de Nanoscope: \u201cTras los resultados positivos del ensayo cl\u00ednico STARLIGHT de fase 2, el resultado de esta reuni\u00f3n refuerza nuestra convicci\u00f3n de avanzar en el desarrollo cl\u00ednico de MCO-010 para esta indicaci\u00f3n. Agradecemos la orientaci\u00f3n de la FDA y esperamos finalizar los preparativos para el ensayo de fase 3\u201d.\u201d<\/p><p>\u201cEl paradigma actual para el manejo de la enfermedad de Stargardt consiste en un diagn\u00f3stico, seguido de rehabilitaci\u00f3n visual y una condena de por vida a una disminuci\u00f3n progresiva de la visi\u00f3n hasta la ceguera severa. El avance de la innovadora terapia de Nanoscope para la enfermedad de Stargardt a un ensayo de registro de fase 3 nos acerca mucho m\u00e1s a tener una opci\u00f3n restauradora viable para los pacientes cuya visi\u00f3n se ha perdido debido a esta terrible enfermedad\u201d, dijo\u00a0<span class=\"xn-person\">Samuel Barone<\/span>, MD, Director M\u00e9dico.<\/p><p>El ensayo de fase 3 previsto ser\u00e1 el primer ensayo de terapia g\u00e9nica aleatorizado y controlado para la enfermedad de Stargardt. El enfoque terap\u00e9utico de Nanoscope, independiente de la mutaci\u00f3n, tiene el potencial de mejorar la visi\u00f3n de muchas otras personas que sufren p\u00e9rdida visual grave, incluidos los pacientes con degeneraci\u00f3n macular.<\/p><p><b>Acerca de la enfermedad de Stargardt<br class=\"dnr\" \/><\/b>La enfermedad de Stargardt, a menudo denominada distrofia macular juvenil, es una enfermedad ocular que se presenta en la infancia y es una de las principales causas de p\u00e9rdida de visi\u00f3n en ni\u00f1os y adultos j\u00f3venes. Es una enfermedad hereditaria, lo que significa que se transmite a los hijos a trav\u00e9s de genes defectuosos de sus padres. En los pacientes con enfermedad de Stargardt, las c\u00e9lulas fotorreceptoras sensibles a la luz en la m\u00e1cula se degradan, lo que provoca la p\u00e9rdida de la visi\u00f3n central. Actualmente, no existen tratamientos aprobados.<\/p><p><b>Acerca de Nanoscope Therapeutics, Inc.<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando terapias optogen\u00e9ticas que restauran la visi\u00f3n, independientes del gen, para los millones de pacientes ciegos por enfermedades degenerativas de la retina, para las cuales no existe cura. El principal activo de la compa\u00f1\u00eda, MCO-010, inform\u00f3 recientemente los resultados preliminares del ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo RESTORE Fase 2b en los EE. UU. para la retinosis pigmentaria (RP) (<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4253597-1&h=3186461145&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3939588-1%26h%3D1414634841%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3823946-1%2526h%253D153867349%2526u%253Dhttps%25253A%25252F%25252Fclinicaltrials.gov%25252Fct2%25252Fshow%25252FNCT04945772%25253Fterm%25253DNanoscope%252526draw%25253D2%2526a%253DNCT04945772%26a%3DNCT04945772&a=NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>). La empresa tambi\u00e9n ha completado el ensayo de fase 2 STARLIGHT de MCO-010 en pacientes con enfermedad de Stargardt (<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4253597-1&h=3896378782&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3939588-1%26h%3D1223114861%26u%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fct2%252Fshow%252FNCT05417126%26a%3DNCT05417126&a=NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>). El MCO-010 ha recibido la designaci\u00f3n de v\u00eda r\u00e1pida de la FDA y la designaci\u00f3n de medicamento hu\u00e9rfano de la FDA tanto para la RP como para la enfermedad de Stargardt. Los activos precl\u00ednicos incluyen la terapia g\u00e9nica MCO020 administrada con l\u00e1ser no viral para la atrofia geogr\u00e1fica.<\/p><p><b>Contacto de inversores:<\/b><br class=\"dnr\" \/>Socios Argot<br class=\"dnr\" \/>(212) 600-1902<br class=\"dnr\" \/><a href=\"mailto:pr@nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">pr@nanostherapeutics.com<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/section>\r\n\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Phase 3 Registrational Trial Expected to Commence in Near-term DALLAS,\u00a0Sept. 12, 2024\u00a0 \u2014 Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for retinal degenerative diseases and age-related macular degeneration (AMD), today announced a productive End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5777,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[13,8],"tags":[],"class_list":["post-5775","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Therapeutics Announces End-of-Phase 2 Meeting with U.S. FDA and Plan to Initiate a Phase 3 Clinical Trial of MCO-010 to Treat Stargardt Macular Degeneration - Nanoscope Therapeutics<\/title>\n<meta name=\"description\" content=\"Our multi-characteristic opsin (MCO) platform is the first to demonstrate an ability to restore vision to retinal disease patients with severe vision loss in clincial trials. Nanoscope has developed MCO-010, the first and only broad spectrum, fast response and ultra-sensitive optogenetic technology for vision restoration that is gene-agnostic.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nanostherapeutics.com\/es\/2024\/09\/12\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-u-s-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Therapeutics Announces End-of-Phase 2 Meeting with U.S. FDA and Plan to Initiate a Phase 3 Clinical Trial of MCO-010 to Treat Stargardt Macular Degeneration - Nanoscope Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Our multi-characteristic opsin (MCO) platform is the first to demonstrate an ability to restore vision to retinal disease patients with severe vision loss in clincial trials. 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