Ua hoʻolaha ʻo Kodiak Sciences Inc. i kēia lā i nā hopena o ka laina kiʻekiʻe mai kāna hoʻokolohua hoʻokolohua hoʻokolohua hoʻohālikelike ʻelua, pālua-masked, ikaika hoʻohālikelike hoʻohālikelike i ka Phase 2b/3 e loiloi ana i ka pono, ka lōʻihi a me ka palekana o KSI-301, kahi mea hou antibody biopolymer conjugate, i ka mālama ʻole. nā kumuhana me ka neovascular (mākū) pili i ka macular degeneration makahiki.
Ua hoʻopaʻa ʻia ka hoʻāʻo ʻana i 559 mau mea komo, ma kahi o 80% o lākou i kākau inoa ʻia ma ʻAmelika Hui Pū ʻIa. Ua loaʻa i ka haʻawina ʻelua mau lima lapaʻau: KSI-301 5mg ma kahi regimen lōʻihi lōʻihi a aflibercept 2mg ma kahi regimen wā pōkole paʻa. I loko o ke aʻo ʻana, ua hāʻawi ʻia ʻekolu mau kau hoʻouka ʻana i kēlā me kēia mahina i nā kumuhana āpau ma 0-, 4- a me 8-wiki. A laila mālama ʻia nā mea pili i ka aflibercept i 2 mau mahina. Ua loiloi ʻia nā kumuhana ma KSI-301 e hoʻomaka ana i nā mahina 3 ma hope o ka pau ʻana o ka pae hoʻouka (ʻo ia hoʻi e hoʻomaka ana ma 20 mau pule) a, ma muli o nā koina hana maʻi i koho mua ʻia, mālama ʻia i kēlā me kēia 3-, 4-, a i ʻole 5 mau mahina. ʻO ka hopena, ʻaʻole i loaʻa i nā poʻe maʻi i ka hui KSI-301 ka dosing pinepine ma mua o kēlā me kēia 3 mahina i kēlā me kēia manawa o ke aʻo ʻana ma hope o ka pae hoʻouka. ʻO ka hopena mua o ke aʻo ʻana, ʻo ia ka hoʻololi awelika o ka helu ʻike maikaʻi loa i hoʻoponopono ʻia (BCVA) (he ana o ka ʻike maikaʻi loa e hiki ke loaʻa i ke kanaka ke heluhelu ʻana i nā leka ma ka pakuhi maka, me ka hoʻoponopono ʻana e like me nā aniani) mai ka papa kuhikuhi i ka makahiki. 1. No ka loiloi ʻana i ka hopena hopena mua, ua hui pū ʻia nā mea maʻi KSI-301 i nā hui ʻekolu (dosed i kēlā me kēia 3, 4 a i ʻole 5 mau mahina) a ua hoʻohālikelike ʻia kā lākou BCVA ma ke ʻano he hui i ka hui aflibercept (hoʻohana ʻia i kēlā me kēia 2 mahina) .
Hōʻike nā hualoaʻa, ʻoiai ua hōʻike ʻo KSI-301 i ka paʻa ikaika a palekana a ʻae ʻia, ʻaʻole ia i hoʻokō i ka hopena hopena mua o ka hōʻike ʻana i nā loaʻa ʻike ʻike ʻole haʻahaʻa no nā kumuhana i hoʻopaʻa ʻia i nā regimen lōʻihi i hoʻohālikelike ʻia me aflibercept i hāʻawi ʻia i kēlā me kēia ʻewalu pule.
Ua hōʻike ʻia kahi loiloi lua mua i ka makahiki 1 e loiloi ana i ka lōʻihi o ka 59% o nā mea maʻi ma ka lima KSI-301 i loaʻa i ka dosing ʻelima mau mahina me ka loaʻa ʻana o ka ʻike acuity a me nā hoʻomaikaʻi anatomic e like me ka hui aflibercept holoʻokoʻa.
Ua palekana a ʻae maikaʻi ʻia ʻo KSI-301 i ke aʻo ʻana, ʻaʻohe hōʻailona palekana hou i ʻike ʻia.
He aha e lawe ʻia mai kēia ʻatikala:
- 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.
