Kodiak Sciences Inc. dina iki ngumumake asil paling dhuwur saka uji klinis Fase 2b/3 sing dikontrol komparator kanthi acak, topeng ganda, aktif sing ngevaluasi khasiat, daya tahan lan safety KSI-301, konjugat biopolimer antibodi novel, ing perawatan-naif. subyek kanthi degenerasi makula sing gegandhengan karo umur neovaskular (udan).

Uji coba kasebut kanthi acak 559 peserta, kira-kira 80% sing didaftarkan ing Amerika Serikat. Panaliten kasebut duwe rong senjata perawatan: KSI-301 5mg ing regimen interval dawa sing fleksibel lan aflibercept 2mg ing regimen interval cendhak tetep. Ing panliten kasebut, telung dosis loading saben wulan diwenehake kanggo kabeh subyek ing 0-, 4- lan 8 minggu. Subyek ing aflibercept banjur diobati kanthi interval 2 wulan tetep. Subjek ing KSI-301 ditaksir wiwit 3 sasi sawise rampung fase loading (yaiku diwiwiti ing 20 minggu) lan, adhedhasar kritéria aktivitas penyakit sing wis ditemtokake, diobati saben 3-, 4-, utawa 5 sasi. Akibaté, pasien ing klompok KSI-301 ora nampa dosis luwih kerep tinimbang saben 3 sasi ing sembarang titik ing panliten sawise fase loading. Titik pungkasan utama panaliten yaiku owah-owahan rata-rata skor ketajaman visual sing paling apik (BCVA) (ukuran visi paling apik sing bisa digayuh nalika maca huruf ing grafik mripat, kalebu koreksi kayata kacamata) saka garis dasar ing taun. 1. Kanggo evaluasi titik akhir khasiat utama, pasien KSI-301 ing kabeh telung klompok (dosis saben 3, 4 utawa 5 sasi) dikumpulake bebarengan lan BCVA dibandhingake karo klompok aflibercept (dosis saben 2 wulan). .

Asil kasebut nuduhake manawa, sanajan KSI-301 nuduhake daya tahan sing kuat lan aman lan ditoleransi kanthi apik, nanging ora bisa nggayuh titik pungkasan khasiat utama kanggo nuduhake asil ketajaman visual sing ora inferior kanggo subyek sing diobati kanthi regimen sing luwih dawa dibandhingake karo aflibercept sing diwenehake saben wolung minggu.

Analisis sekunder sing wis ditemtokake ing taun 1 ngevaluasi daya tahan nuduhake 59% pasien ing lengen KSI-301 entuk dosis limang sasi kanthi paningkatan ketajaman visual lan perbaikan anatomi sing bisa dibandhingake karo klompok aflibercept sakabèhé.

KSI-301 aman lan ditrima kanthi apik ing panliten kasebut, tanpa sinyal keamanan anyar sing diidentifikasi.

APA sing kudu dijupuk saka ARTIKEL INI:

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.