{"id":5670,"date":"2024-03-26T06:39:12","date_gmt":"2024-03-26T11:39:12","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5670"},"modified":"2025-06-27T11:20:37","modified_gmt":"2025-06-27T16:20:37","slug":"nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2024\/03\/26\/nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope Therapeutics anuncia resultados positivos de primera l\u00ednea del ensayo controlado aleatorio de MCO-010 para la retinitis pigmentosa"},"content":{"rendered":"<div class=\"col-sm-8 col-vcenter col-xs-12\">\n<div class=\"col-sm-8 col-vcenter col-xs-12\">\n<h1><\/h1>\n<ul type=\"disc\">\n<li><strong><i>MCO-010 logr\u00f3 sus criterios de valoraci\u00f3n primarios y secundarios clave con significaci\u00f3n estad\u00edstica y sin eventos adversos graves<\/i><\/strong><\/li>\n<li><strong><i>Datos de la Fase\u00a0<span class=\"xn-money\">2b<\/span>\u00a0El ensayo RESTORE demuestra una mejora de la visi\u00f3n cl\u00ednicamente significativa en personas legalmente ciegas con neurodegeneraci\u00f3n progresiva y permanente de la retina<\/i><\/strong><\/li>\n<li><strong><i>RESTORE es el primer ensayo controlado y aleatorizado de una terapia gen\u00e9tica independiente de las mutaciones para una enfermedad gen\u00e9tica<\/i><\/strong><\/li>\n<li><strong><i>Nanoscope prev\u00e9 presentar una Solicitud de Licencia de Productos Biol\u00f3gicos (BLA) a la Administraci\u00f3n de Medicamentos y Alimentos de EE. UU. (FDA) en la segunda mitad de 2024<\/i><\/strong><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<article class=\"news-release inline-gallery-template\">\n<section class=\"release-body container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-lg-offset-1\">\n<p><span class=\"xn-location\">DALLAS<\/span>,\u00a0<span class=\"xn-chron\">26 de marzo de 2024<\/span> \u2014\u00a0<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 hereditarias de la retina y degeneraciones maculares relacionadas con la edad (DMAE), anunci\u00f3 hoy resultados positivos de primera l\u00ednea despu\u00e9s de la finalizaci\u00f3n de la fase de 2 a\u00f1os.\u00a0<span class=\"xn-money\">2b<\/span>\u00a0RESTORE ensayo cl\u00ednico controlado y aleatorizado de su programa principal, MCO-010<i>,<\/i>\u00a0una terapia g\u00e9nica independiente de las mutaciones para pacientes con p\u00e9rdida de visi\u00f3n permanente y grave debido a retinitis pigmentosa (RP) avanzada.<\/p>\n<p>El ensayo cumpli\u00f3 su criterio de valoraci\u00f3n principal, demostrando una mejora estad\u00edsticamente significativa de la agudeza visual mejor corregida (MAVC) en la semana 52 tanto en dosis alta (0,337 LogMAR; p=0,021) como en dosis baja (0,382 LogMAR; p=0,029). grupos de tratamiento en comparaci\u00f3n con el grupo de control simulado (0,050 LogMAR). La fase\u00a0<span class=\"xn-money\">2b<\/span>\u00a0El ensayo RESTORE representa el \u00fanico ensayo controlado aleatorizado en enfermedades degenerativas de la retina que ha demostrado una mejor\u00eda m\u00e1s all\u00e1 del umbral cl\u00ednicamente importante de BCVA &gt; 0,3 LogMAR de manera estad\u00edsticamente significativa.<\/p>\n<p>Las mejoras en la funci\u00f3n visual persistieron o aumentaron despu\u00e9s de la semana 52 del estudio, lo que demuestra el efecto duradero de una \u00fanica inyecci\u00f3n intrav\u00edtrea de MCO-010. La mejora de la BCVA en la semana 76, un criterio de valoraci\u00f3n secundario clave, fue estad\u00edsticamente significativa en el grupo de tratamiento con dosis altas en comparaci\u00f3n con el grupo de control (0,539 LogMAR; p=0,001). En la semana 76, la mejora en la MAVC en el grupo de tratamiento de dosis baja no fue estad\u00edsticamente significativa en comparaci\u00f3n con el control (0,374 LogMAR; p=0,065)<i>.<\/i>\u00a0Estos resultados son consistentes con lo que se ha observado previamente en el estudio abierto de Fase 1\/2a anterior. Est\u00e1 previsto que la dosis comercial sea la dosis alta de MCO-010 (1,2E11gc\/ojo).<\/p>\n<p>En otro criterio de valoraci\u00f3n secundario preespecificado, el criterio de valoraci\u00f3n funcional compuesto de la novedosa discriminaci\u00f3n de formas de m\u00faltiples luminancias y las pruebas de movilidad y mostraron una tasa de respuesta de 89% tanto en el grupo de tratamiento de dosis alta como en el de dosis baja en la semana 52, lo que ofrece un mayor apoyo a la visi\u00f3n. mejora despu\u00e9s de la administraci\u00f3n de MCO-010. Se presentar\u00e1n datos adicionales de este ensayo cl\u00ednico en una serie de reuniones cient\u00edficas en los pr\u00f3ximos meses, comenzando con una presentaci\u00f3n en la Reuni\u00f3n Cient\u00edfica Anual de la Asociaci\u00f3n para la Investigaci\u00f3n en Visi\u00f3n y Oftalmolog\u00eda sobre\u00a0<span class=\"xn-chron\">6 de mayo de 2024<\/span>, en\u00a0<span class=\"xn-location\">Seattle, Washington<\/span>, por\u00a0<span class=\"xn-person\">Allen Ho<\/span>, MD, Director de Investigaci\u00f3n de Retina y Codirector del Servicio de Retina en Wills Eye Hospital.<\/p>\n<p>MCO-010 fue generalmente bien tolerado y no se informaron eventos adversos graves o graves relacionados con el tratamiento, de acuerdo con estudios anteriores. Los eventos adversos m\u00e1s comunes fueron hipertensi\u00f3n ocular y de c\u00e9lulas de la c\u00e1mara anterior leve o moderada. En los grupos de tratamiento no se informaron eventos adversos de especial inter\u00e9s relacionados con la inflamaci\u00f3n intraocular, como endoftalmitis, retinitis, vasculitis retiniana, vasculitis oclusiva retiniana o hipoton\u00eda.<\/p>\n<p>\u201cObservamos una recuperaci\u00f3n significativa de la visi\u00f3n en muchos pacientes con p\u00e9rdida visual severa, incluidos aquellos que estaban completamente ciegos\u201d, dijo.\u00a0<span class=\"xn-person\">David Boyer<\/span>, MD, investigador del ensayo y profesor cl\u00ednico adjunto de oftalmolog\u00eda en el\u00a0<span class=\"xn-org\">Universidad del Sur de California<\/span>\u00a0Facultad de Medicina Keck. \u201cMuchos pacientes tratados con MCO-010 obtuvieron un beneficio cl\u00ednicamente significativo, medible en la prueba primaria de funci\u00f3n visual, y este efecto se confirm\u00f3 mediante una mejora paralela en las evaluaciones de la visi\u00f3n funcional. De ser aprobado, MCO-010 tiene el potencial de generar un impacto positivo y significativo en la vida de los pacientes afectados por esta enfermedad debilitante\u201d.\u201d<\/p>\n<p>Con base en estos resultados, Nanoscope tiene la intenci\u00f3n de presentar una BLA a la FDA de EE. UU. en la segunda mitad de 2024 como primer paso en la ejecuci\u00f3n de su estrategia global de regulaci\u00f3n y comercializaci\u00f3n.<\/p>\n<p>\u201cMe entusiasma ver que MCO-010 tiene el potencial de mejorar la visi\u00f3n en pacientes con retinosis pigmentaria avanzada\u201d, dijo\u00a0<span class=\"xn-person\">Arshad M. Khanani<\/span>, MD, MA, FASRS, Director de Investigaci\u00f3n Cl\u00ednica en Sierra Eye Associates y Profesor Cl\u00ednico en el\u00a0<span class=\"xn-org\">Universidad de Nevada, Reno<\/span>\u00a0Facultad de Medicina. \u201cEste es un momento crucial para el campo de la terapia g\u00e9nica ocular, ya que contamos con un posible tratamiento intrav\u00edtreo independiente de la mutaci\u00f3n para la retinosis pigmentaria, una enfermedad que actualmente no tiene tratamiento disponible y que provoca una p\u00e9rdida permanente de la visi\u00f3n\u201d.\u201d<\/p>\n<p>\u201cNanoscope est\u00e1 a la vanguardia en el avance de la optogen\u00e9tica hacia una soluci\u00f3n terap\u00e9utica tangible para pacientes con retinosis pigmentaria\u201d, afirm\u00f3.\u00a0<span class=\"xn-person\">Sulagna Bhattacharya<\/span>, cofundador y director ejecutivo de Nanoscope. \u201cLos datos convincentes de los an\u00e1lisis m\u00e1s recientes del ensayo RESTORE en la semana 76 proporcionan una validaci\u00f3n adicional de la vers\u00e1til plataforma MCO de Nanoscope, que impulsa nuestra creciente cartera de programas tanto para la enfermedad de Stargardt como para la atrofia geogr\u00e1fica (AG) debida a la degeneraci\u00f3n macular asociada a la edad (DMAE). Extendemos nuestro m\u00e1s sincero agradecimiento a los participantes del ensayo y a sus familias, as\u00ed como a los investigadores y a todos aquellos que contribuyeron a este innovador ensayo y a su exitosa finalizaci\u00f3n\u201d.\u201d<\/p>\n<p>Estos resultados representan la primera evidencia de la eficacia de una terapia gen\u00e9tica independiente de las mutaciones para una enfermedad gen\u00e9tica. Estos resultados reflejan m\u00e1s de una d\u00e9cada de innovaci\u00f3n en todos los aspectos del programa MCO-010, incluido el dise\u00f1o de vectores, la fabricaci\u00f3n y el dise\u00f1o de ensayos cl\u00ednicos, as\u00ed como el desarrollo de nuevos criterios de valoraci\u00f3n funcionales de la visi\u00f3n para esta poblaci\u00f3n con p\u00e9rdida grave de la visi\u00f3n.<\/p>\n<p>\u201cEstos resultados son la culminaci\u00f3n de m\u00e1s de una d\u00e9cada de trabajo de numerosas personas dedicadas, lo que subraya el potencial de nuestra plataforma MCO-010, \u00fanica en su tipo, de banda ancha, altamente fotosensible y r\u00e1pida\u201d, dijo.\u00a0<span class=\"xn-person\">Samarendra Mohanty<\/span>, PhD, cofundador, presidente y director cient\u00edfico de Nanoscope. \u201cEste logro marca un hito significativo en el campo de la terapia g\u00e9nica independiente de la mutaci\u00f3n, consolidando el potencial de la optogen\u00e9tica como modalidad terap\u00e9utica. Expresamos nuestro sincero agradecimiento al Instituto Nacional del Ojo (NIH) y a sus colaboradores por sus invaluables contribuciones para hacer realidad el potencial terap\u00e9utico de la terapia MCO, ofreciendo esperanza de recuperaci\u00f3n de la visi\u00f3n a pacientes independientemente de su mutaci\u00f3n gen\u00e9tica subyacente\u201d.\u201d<\/p>\n<p><b>RESTAURAR Detalle de prueba<br class=\"dnr\" \/><\/b>El multic\u00e9ntrico, Fase\u00a0<span class=\"xn-money\">2b<\/span>\u00a0El ensayo aleatoriz\u00f3 a 28 sujetos con p\u00e9rdida grave de visi\u00f3n y diagn\u00f3stico cl\u00ednico confirmado de RP. Un sujeto asignado al azar, que retir\u00f3 su consentimiento antes de las mediciones iniciales y la intervenci\u00f3n del estudio, no fue incluido en la poblaci\u00f3n mITT. Los resultados informados provienen de la poblaci\u00f3n mITT que incluy\u00f3 a todos los sujetos asignados al azar que recibieron la intervenci\u00f3n en el ojo del estudio (MCO-010 o control): 18 sujetos en los grupos MCO-010 y 9 sujetos en el grupo de control. Para los criterios de valoraci\u00f3n primarios y secundarios clave, los sujetos fueron evaluados en m\u00faltiples momentos durante dos a\u00f1os para evaluar la BCVA, medida mediante la prueba de agudeza visual de Friburgo.<\/p>\n<ul type=\"disc\">\n<li>Se realiz\u00f3 un modelo lineal de efectos mixtos para medidas repetidas (MMRM) en los criterios de valoraci\u00f3n primarios y secundarios clave, donde los datos de agudeza visual de todas las visitas posteriores al inicio se incluyeron en el modelo, con la agudeza visual inicial como covariable.<\/li>\n<li>Las comparaciones entre los grupos de tratamiento se realizaron utilizando un procedimiento de Hochberg para ajustar las comparaciones m\u00faltiples con el control. Utilizando los resultados obtenidos del modelo MMRM, el\u00a0<i>pag-<\/i>Los valores de las dos comparaciones de los grupos de MCO-010 versus el control se ordenaron de mayor a menor.<\/li>\n<li>Los resultados de los criterios de valoraci\u00f3n de agudeza visual primarios y secundarios clave que se informan se basan en discusiones regulatorias,\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4123320-1&h=1781377654&u=https%3A%2F%2Fnanostherapeutics.com%2F2024%2F01%2F18%2Fnanoscope-therapeutics-provides-regulatory-update-on-mco-010-for-the-treatment-of-retinitis-pigmentosa%2F&a=as+previously+announced+on+January+18%2C+2024\" target=\"_blank\" rel=\"nofollow noopener\">como se anunci\u00f3 previamente el\u00a0<span class=\"xn-chron\">18 de enero de 2024<\/span><\/a>y alinear los criterios de valoraci\u00f3n del estudio con los objetivos del estudio previstos originalmente. Se finaliz\u00f3 un plan de an\u00e1lisis estad\u00edstico (SAP) revisado y se present\u00f3 a los reguladores antes de la finalizaci\u00f3n de la semana 76 y puntos temporales posteriores del estudio.<\/li>\n<li>La visi\u00f3n funcional se evalu\u00f3 evaluando el desempe\u00f1o del sujeto en el reconocimiento de objetos o navegando en un curso de movilidad bajo una variedad de niveles de luz encontrados en las actividades de la vida diaria.<\/li>\n<\/ul>\n<p>A continuaci\u00f3n se presenta un resumen de los resultados de eficacia de primera l\u00ednea:<\/p>\n<div>\n<div class=\"divOverflow\">\n<div class=\"table-responsive\">\n<table class=\"prnbcc\" border=\"0\" width=\"\" cellspacing=\"0\" cellpadding=\"1\">\n<tbody>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"2\" width=\"\" height=\"\"><\/td>\n<td class=\"prngen2\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>Variable principal:<\/i><\/b><i>\u00a0BCVA en la semana 52<\/i><\/span><\/p>\n<\/td>\n<td class=\"prnpr2 prnpl2 prnvab prncbts prnbrbrs prnbbbs prnsblb1\" colspan=\"2\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>Criterio de valoraci\u00f3n secundario clave:<\/i><\/b><i>\u00a0BCVA en la semana 76<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>Cambio en LogMAR de<br class=\"dnr\" \/>Valor inicial (media \u00b1 SEM)<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>Valor p<\/i><\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>frente a control<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>Cambio en LogMAR de<br class=\"dnr\" \/>Valor inicial (media \u00b1 SEM)<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>Valor p<\/i><\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>frente a control<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>Dosis alta MCO-010<\/i><\/b><\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>(1,2E11 gc, N=9)<\/i><\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,337 \u00b10,0829<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>0.0209<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,539 \u00b1 0,1032<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>0.0014<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>Dosis baja MCO-010<\/i><\/b><\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>(0,9E11 gc, N=9)<\/i><\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,382 \u00b10,1244<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>0.0290<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,374 \u00b1 0,1332<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>0.0652<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"prngen5\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>control simulado<\/i><\/b><\/span><\/p>\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><b><i>(N=9)<\/i><\/b><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,050 \u00b10,0717<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>\u2014-<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>-0,078 \u00b1 0,0737<\/i><\/span><\/p>\n<\/td>\n<td class=\"prngen4\" colspan=\"1\" rowspan=\"1\" width=\"\" height=\"\">\n<p class=\"prnml4 dnr\"><span class=\"prnews_span\"><i>\u2014-<\/i><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><b>Acerca de la retinosis pigmentaria<br class=\"dnr\" \/><\/b>La retinosis pigmentaria (RP) engloba un grupo de trastornos gen\u00e9ticos raros en los que las c\u00e9lulas fotorreceptoras de la retina se degeneran con el tiempo, lo que provoca deterioro visual y, finalmente, ceguera. Se cree que estos trastornos est\u00e1n relacionados con m\u00e1s de 100 mutaciones gen\u00e9ticas diferentes. Aproximadamente 100\u00a0000 personas en Estados Unidos y unos 2 millones en todo el mundo padecen RP, lo que la convierte en la principal causa de ceguera hereditaria.<\/p>\n<p><b>Acerca de MCO-010<br class=\"dnr\" \/><\/b>Las terapias gen\u00e9ticas actuales tienen como objetivo tratar a pacientes con mutaciones gen\u00e9ticas espec\u00edficas y est\u00e1n a\u00fan m\u00e1s limitadas en enfermedades avanzadas con c\u00e9lulas degeneradas de la retina externa. La monoterapia optogen\u00e9tica MCO activable con luz ambiental se dirige a abundantes neuronas internas de la retina y tiene el potencial de restaurar la visi\u00f3n perdida permanentemente debido a la RP avanzada. MCO-010 (<i>sonpiretigene isteparvovec<\/i>, suspensi\u00f3n para inyecci\u00f3n intrav\u00edtrea) es la \u00fanica opsina de banda ancha, r\u00e1pida y altamente sensible a la luz que se encuentra actualmente en ensayos cl\u00ednicos. Con orientaci\u00f3n a c\u00e9lulas bipolares mediante el potenciador del promotor mGluR6, el casete de expresi\u00f3n MCO-010 est\u00e1 dise\u00f1ado para restaurar la visi\u00f3n de alta calidad en entornos del mundo real. El vector patentado AAV2 permite una transducci\u00f3n robusta de MCO-010 en c\u00e9lulas bipolares tras inyecci\u00f3n intrav\u00edtrea. El estudio de fase 1\/2a de MCO-010 en pacientes con RP avanzada demostr\u00f3 una seguridad favorable y una mejora de la agudeza visual dependiente de la dosis.<\/p>\n<p><b>Acerca de Nanoscope Therapeutics Inc.<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando terapias optogen\u00e9ticas independientes del gen que restauran la visi\u00f3n para millones de pacientes ciegos por enfermedades retinianas hereditarias para las que no existe cura. El principal f\u00e1rmaco de la compa\u00f1\u00eda, MCO-010, complet\u00f3 recientemente la fase RESTORE.\u00a0<span class=\"xn-money\">2b<\/span>\u00a0ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble enmascarado y controlado de forma simulada en los EE. UU. para la retinosis pigmentaria (NCT04945772). La compa\u00f1\u00eda tambi\u00e9n complet\u00f3 recientemente el ensayo STARLIGHT de fase 2 de la terapia MCO-010 en pacientes con enfermedad de Stargardt (NCT05417126). MCO-010 ha recibido designaciones de v\u00eda r\u00e1pida de la FDA y designaciones 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 MCO-020 administrada con l\u00e1ser no viral para la GA debida a la DMAE.<\/p>\n<p><b>Contacto de inversores:<\/b><br class=\"dnr\" \/>Socios Argot<br class=\"dnr\" \/>212-600-1902<br class=\"dnr\" \/><a href=\"mailto:Nanoscope@argotpartners.com\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscope@argotpartners.com<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>MCO-010 achieved its primary and key secondary endpoints with statistical significance and no serious adverse events Data from the Phase\u00a02b\u00a0RESTORE trial demonstrate clinically meaningful vision improvement in legally blind individuals with progressive and permanent neurodegeneration of the retina RESTORE is the first randomized, controlled trial of a mutation-agnostic gene therapy for a genetic disease Nanoscope [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5671,"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-5670","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 Positive Top-line Results from Randomized Controlled Trial of MCO-010 for Retinitis Pigmentosa - 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. 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