I-Kodiak Sciences Inc. namhlanje ibhengeze iziphumo zodidi oluphezulu ukusuka kwi-randomized, imaski ephindwe kabini, esebenzayo elawulwa ngumthelekisi-olawulwa kwiSigaba se-2b/3 solingo lwezonyango oluvavanya ukusebenza, ukuqina kunye nokhuseleko lwe-KSI-301, inoveli ye-antibody biopolymer conjugate, kunyango-naïve. izifundo ezine-neovascular (ezimanzi) ezinxulumene nobudala be-macular degeneration.
Ulingo lwenza ngokungakhethiyo abathathi-nxaxheba abangama-559, malunga nama-80% kubo ababhalise eUnited States. Uphononongo lwaluneengalo ezimbini zonyango: i-KSI-301 5mg kwirejimeni eguquguqukayo yexesha elide kunye ne-aflibercept 2mg kwirejimeni emiselweyo yexesha elifutshane. Kuphononongo, iidosi ezintathu zokulayisha ngenyanga zilawulwa kuzo zonke izifundo kwi-0-, 4- kunye ne-8-iveki. Izifundo kwi-aflibercept zaye zaphathwa ngamaxesha amiselweyo eenyanga ezi-2. Izifundo kwi-KSI-301 zavavanywa ukuqala kwiinyanga ezi-3 emva kokugqitywa kwesigaba sokulayisha (oko kukuthi, ukuqala kwiiveki ezingama-20) kwaye, ngokusekelwe kwiikhrayitheriya ezichazwe kwangaphambili zesifo, zaphathwa rhoqo kwiinyanga ezi-3, ezi-4, okanye ezi-5. Ngenxa yoko, izigulane kwiqela le-KSI-301 azizange zifumane i-dosing rhoqo ngaphezu kweenyanga zonke ze-3 nakweyiphi na indawo kwisifundo emva kwesigaba sokulayisha. Isiphelo esiphambili sokufunda sasiyinguqu ephakathi kwi-best-corrected acuity visual acuity (BCVA) (umlinganiselo wombono ongcono kakhulu onokuwufumana umntu xa efunda iileta kwitshathi yamehlo, kubandakanywa nokulungiswa okufana neeglasi) ukusuka kwisiseko ngonyaka. 1. Uvavanyo lwe-primary efficacy endpoint, izigulane ze-KSI-301 kuwo onke amaqela amathathu (i-dose nganye kwii-3, i-4 okanye iinyanga ze-5) zahlanganiswa kunye kunye ne-BCVA yabo yafaniswa njengeqela kwiqela le-aflibercept (idosi nganye kwiinyanga ze-2) .
Iziphumo zibonisa ukuba, nangona i-KSI-301 ibonise ukuqina olomeleleyo kwaye ikhuselekile kwaye inyamezeleke kakuhle, ayizange ihlangabezane nesiphelo sokusebenza esisisiseko sokubonisa ukuzuzwa kobuchule bokubona obungekho ngaphantsi kwezifundo ezithathiweyo kwiirejimeni ezandisiweyo xa kuthelekiswa ne-aflibercept enikwa rhoqo kwiiveki ezisibhozo.
Uhlalutyo lwesibini oluxelwe kwangaphambili kunyaka we-1 wokuvavanya ukuqina lubonise i-59% yezigulane kwi-KSI-301 ingalo iphumelele i-dosing yeenyanga ezintlanu kunye neenzuzo ezibonakalayo kunye nophuculo lwe-anatomic oluthelekiswa neqela lonke le-aflibercept.
I-KSI-301 yayikhuselekile kwaye inyamezeleke kakuhle kuphononongo, kungekho zimpawu zintsha zokhuseleko ezichongiweyo.
INTO ONOKUYITHATHA KWELI NQAKU:
- The primary endpoint of the study was the average change in best-corrected visual acuity (BCVA) score (a measure of the best vision a person can achieve when reading letters on an eye chart, including with correction such as glasses) from baseline at year 1.
- For the assessment of the primary efficacy endpoint, KSI-301 patients in all three groups (dosed every 3, 4 or 5 months) were pooled together and their BCVA was compared as a group to the aflibercept group (dosed every 2 months).
- As a result, patients in the KSI-301 group did not receive dosing more frequently than every 3 months at any point in the study after the loading phase.
