Sakamako mai Kyau a cikin Marasa lafiya masu Alakar Macular Degeneration mai alaƙa da Shekarun Jijiya

Kodiak Sciences Inc. a yau ta sanar da sakamako na saman layi daga bazuwar sa, mai rufe fuska biyu, gwajin gwaji na gwaji na gwaji na Phase 2b/3 wanda ke kimanta inganci, dorewa da amincin KSI-301, wani sabon labari na antibody bioopolymer conjugate, a cikin jiyya- butulci. batutuwa tare da ciwon daji (rigar) shekaru masu alaka da macular degeneration.

Gwajin ya bazu mahalarta 559, kusan 80% daga cikinsu sun yi rajista a Amurka. Binciken yana da makamai biyu na jiyya: KSI-301 5mg akan tsarin lokaci mai sassaucin ra'ayi da kuma yarda da 2mg akan ƙayyadaddun tsarin gajeren lokaci. A cikin binciken, an ba da allurai uku na lodawa kowane wata ga duk batutuwa a makonni 0-, 4- da 8. Abubuwan da aka yarda da su sannan an bi da su a ƙayyadaddun tazara na watanni 2. Abubuwan da ke kan KSI-301 an tantance su tun daga watanni 3 bayan kammala lokacin lodi (watau farawa daga makonni 20) kuma, bisa ƙayyadaddun ƙayyadaddun ayyukan cutar, ana bi da su kowane watanni 3-, 4-, ko 5. Sakamakon haka, marasa lafiya a cikin ƙungiyar KSI-301 ba su sami allurai akai-akai fiye da kowane watanni 3 ba a kowane lokaci a cikin binciken bayan lokacin ɗaukar nauyi. Babban mahimmancin binciken shine matsakaicin canji a cikin mafi kyawun gyaran gani na gani (BCVA) (ma'auni na mafi kyawun hangen nesa da mutum zai iya cimma lokacin karanta haruffa akan taswirar ido, gami da gyara irin su gilashin) daga tushe a shekara. 1. Don ƙididdige ƙimar ƙimar ƙimar farko, marasa lafiya na KSI-301 a cikin duk ƙungiyoyi uku (wanda aka yi wa kowane watanni 3, 4 ko 5) an haɗa su tare kuma an kwatanta su da BCVA a matsayin rukuni zuwa ƙungiyar masu yarda (ana yin allura kowane watanni 2). .

Sakamakon ya nuna cewa, ko da yake KSI-301 ya nuna ƙarfi mai ƙarfi kuma yana da aminci kuma an jure shi sosai, bai dace da ƙarshen ingantaccen matakin nuna ƙimar gani mara ƙarancin gani ba ga batutuwan da aka ƙididdige su akan tsawaita lokaci idan aka kwatanta da yarda da ake bayarwa kowane mako takwas.

Wani bincike na sakandare da aka ƙayyade a shekara ta 1 yana kimanta dorewa ya nuna 59% na marasa lafiya a cikin hannun KSI-301 sun sami allurai na tsawon watanni biyar tare da ci gaban gani na gani da haɓakar jikin mutum kwatankwacin ƙungiyar gabaɗayan yarda.

KSI-301 ya kasance lafiyayye kuma an jure shi sosai a cikin binciken, ba tare da an gano sabbin alamun tsaro ba.