{"id":7200,"date":"2024-05-15T13:55:00","date_gmt":"2024-05-15T11:55:00","guid":{"rendered":"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-godkannande-for-klinisk-studie-med-nex-22\/"},"modified":"2024-05-15T13:55:00","modified_gmt":"2024-05-15T11:55:00","slug":"nanexa-erhaller-godkannande-for-klinisk-studie-med-nex-22","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/nanexa-erhaller-godkannande-for-klinisk-studie-med-nex-22\/","title":{"rendered":"Nanexa erh\u00e5ller godk\u00e4nnande f\u00f6r klinisk studie med NEX-22"},"content":{"rendered":"<div class=\"mfn-preamble\">\n<p><strong>Nanexa AB meddelar idag att den europeiska l\u00e4kemedelsmyndigheten har godk\u00e4nt bolagets kliniska pr\u00f6vningsans\u00f6kan f\u00f6r Fas I-studien med NEX-22. NEX-22 \u00e4r en l\u00e5ngverkande dep\u00e5formulering av GLP-1-analogen liraglutid med Nanexas patenterade PharmaShell\u00ae-system. M\u00e5let \u00e4r att skapa en GLP-1-produkt som kan administreras en g\u00e5ng i m\u00e5naden vid behandling av typ 2-diabetes.<\/strong><\/p>\n<\/div>\n<div class=\"mfn-body\">\n<p>Studien kommer utf\u00f6ras i samarbete med kontraktsforskningorganisationen Profil i Tyskland som \u00e4r h\u00f6gspecialiserade p\u00e5 tidiga kliniska studier inom diabetes och obesitas. Studien \u00e4r uppdelad i flera p\u00e5 varandra f\u00f6ljande dosgrupper d\u00e4r singeldoser av NEX-22 administreras till patienter med typ 2-diabetes f\u00f6r att f\u00f6lja farmakokinetik, s\u00e4kerhet och tolerablitet.<\/p>\n<p>\u201dVi \u00e4r glada \u00f6ver att vara involverade i denna viktiga studie som unders\u00f6ker en formulering av liraglutid med f\u00f6rl\u00e4ngd fris\u00e4ttning med hj\u00e4lp av Nanexas imponerande PharmaShell\u00ae-teknologi. Vi kommer att g\u00f6ra v\u00e5rt yttersta f\u00f6r att r\u00e4ttf\u00e4rdiga det f\u00f6rtroende som ges till oss och ser mycket fram emot att starta den kliniska pr\u00f6vningen\u201d, s\u00e4ger Dr. Tim Heise, Lead Scientist och medgrundare av Profil.<\/p>\n<p>Liraglutid och andra GLP-1-analoger har snabbt blivit viktiga vid behandling av Typ 2-diabetes och obesitas. Den globala marknaden f\u00f6r denna typ av produkter \u00e4r mycket stor och v\u00e4xer med \u00f6kande prevalens av b\u00e5de Typ 2-diabetes och obesitas. F\u00f6rs\u00e4ljningen av GLP-1-substanser visar stark tillv\u00e4xt och GLP-1 och GLP-1\/GIP-l\u00e4kemedel f\u00f6rv\u00e4ntas n\u00e5 en f\u00f6rs\u00e4ljning p\u00e5 \u00f6ver 70 miljarder dollar 2029 f\u00f6r Typ 2-diabetes (1).<\/p>\n<p>\u201dJag \u00e4r givetvis mycket n\u00f6jd med att vi nu f\u00e5tt godk\u00e4nt att starta studien med NEX-22, en produkt som vi bed\u00f6mer har mycket stor potential att n\u00e5 betydande f\u00f6rs\u00e4ljningsniv\u00e5er. Patienter efterfr\u00e5gar produkter med f\u00e4rre behandlingstillf\u00e4llen och vi ser att \u00e4ven de stora l\u00e4kemedelsbolagen uttrycker samma \u00f6nskan. NEX-22 ers\u00e4tter dagliga sprutor av Victoza med enbart en NEX-22 spruta per m\u00e5nad. Studien och de f\u00f6rsta kliniska resultaten i detta projekt blir en viktig milstolpe f\u00f6r oss\u201d, s\u00e4ger David Westberg, vd f\u00f6r Nanexa.<\/p>\n<p>(1) Global Data Type 2 Diabetes Forecast Dec 2022<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-contacts mfn-2376405b3437\">\n<p><strong class=\"mfn-heading-1\">F\u00f6r mer information kontakta:<\/strong><\/p>\n<hr \/>\n<p>David Westberg \u2013 VD, Nanexa AB (publ)\u00a0<br \/>Telefon: 0709-42 83 03<br \/>E-post:\u00a0<a href=\"mailto:david.westberg@nanexa.se\" rel=\"noopener\" target=\"_blank\">david.westberg@nanexa.se<\/a><br \/><a href=\"http:\/\/www.nanexa.com\" rel=\"noopener\" target=\"_blank\">www.nanexa.com<\/a><\/p>\n<p>Bolagets Certified Adviser \u00e4r Carnegie Investment Bank AB (publ).<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-about mfn-c9ba281e2dde\">\n<p><strong class=\"mfn-heading-1\">Om Nanexa AB (publ)<\/strong><\/p>\n<hr \/>\n<p>Nanexa \u00e4r ett l\u00e4kemedelsbolag som utvecklar injicerbara l\u00e4kemedel baserade p\u00e5 det patenterade och innovativa drug delivery-systemet PharmaShell\u00ae \u2013 ett system som m\u00f6jligg\u00f6r n\u00e4sta generations l\u00e5ngverkande injicerbara l\u00e4kemedel med h\u00f6g drug load, tillverkade med atomlagerprecision. Nanexa utvecklar egna produkter och har dessutom samarbetsavtal med flera l\u00e4kemedelsbolag, d\u00e4ribland Novo Nordisk och AstraZeneca.<\/p>\n<p>Nanexas aktie \u00e4r noterad p\u00e5 Nasdaq First North Growth Market i Stockholm (NANEXA).<\/p>\n<\/div>\n<div class=\"mfn-footer mfn-attachment mfn-attachment-general\">\n<p><strong class=\"mfn-heading-1\">Bifogade filer<\/strong><\/p>\n<hr \/>\n<p><a class=\"mfn-generated mfn-primary\" href=\"https:\/\/storage.mfn.se\/6f597a41-1667-421c-a1d9-1ba7f8eb7355\/nanexa-erhaller-godkannande-for-klinisk-studie-med-nex-22.pdf\" rel=\"noopener\" target=\"_blank\">Nanexa erh\u00e5ller godk\u00e4nnande f\u00f6r klinisk studie med NEX-22<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Nanexa AB meddelar idag att den europeiska l\u00e4kemedelsmyndigheten har godk\u00e4nt bolagets kliniska pr\u00f6vningsans\u00f6kan f\u00f6r Fas I-studien med NEX-22. NEX-22 \u00e4r en l\u00e5ngverkande dep\u00e5formulering av GLP-1-analogen liraglutid med Nanexas patenterade PharmaShell\u00ae-system. M\u00e5let \u00e4r att skapa en GLP-1-produkt som kan administreras en g\u00e5ng i m\u00e5naden vid behandling av typ 2-diabetes.<\/p>\n","protected":false},"template":"","class_list":["post-7200","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci_sv","mfn-news-tag-mfn-type-ir_sv","mfn-news-tag-mfn_sv","mfn-news-tag-mfn-ci-other_sv","mfn-news-tag-mfn-lang-sv_sv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanexa erh\u00e5ller godk\u00e4nnande f\u00f6r klinisk studie med NEX-22 - Nanexa AB<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-godkannande-for-klinisk-studie-med-nex-22\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanexa erh\u00e5ller godk\u00e4nnande f\u00f6r klinisk studie med NEX-22 - Nanexa AB\" \/>\n<meta property=\"og:description\" content=\"Nanexa AB meddelar idag att den europeiska l\u00e4kemedelsmyndigheten har godk\u00e4nt bolagets kliniska pr\u00f6vningsans\u00f6kan f\u00f6r Fas I-studien med NEX-22. NEX-22 \u00e4r en l\u00e5ngverkande dep\u00e5formulering av GLP-1-analogen liraglutid med Nanexas patenterade PharmaShell\u00ae-system. 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