Kodiak Sciences Inc. nhasi yakazivisa mhedzisiro yemhando yepamusoro kubva kune yayo randomized, yakapetwa kaviri, inoshanda muenzanisi-inodzorwa Phase 2b/3 kiriniki kuyedza kuongorora kushanda, kusimba uye kuchengetedzeka kweKSI-301, novel antibody biopolymer conjugate, mukurapa-naïve. zvidzidzo zvine neovascular (wet) age-related macular degeneration.
Mhosva yacho yakarongedza vatori vechikamu 559, vangangoita makumi masere muzana avo vakanyoresa muUnited States. Chidzidzo chacho chaiva nemaoko maviri ekurapa: KSI-80 301mg pane inoshanduka-yenguva yakareba regimen uye aflibercept 5mg pane yakagadziriswa yenguva pfupi regimen. Muchidzidzo chacho, matatu pamwedzi ekurodha madosi akaiswa kune ese zvidzidzo pa2-, 0- uye 4-vhiki. Zvidzidzo zve aflibercept zvakabva zvarapwa panguva yakatarwa yemwedzi miviri. Zvidzidzo zveKSI-8 zvakaongororwa kutanga mwedzi mitatu mushure mekupedzwa kwechikamu chekutakura (kureva kutanga pamavhiki e2) uye, zvichienderana nemaitiro ekuita zvirwere zvakagara zvataurwa, zvakarapwa 301-, 3-, kana 20-mwedzi. Nekuda kweizvozvo, varwere muboka reKSI-3 havana kugamuchira dosing kakawanda kupfuura mwedzi yese ye4 chero nguva muchidzidzo mushure mechikamu chekurodha. Mhedziso yekutanga yechidzidzo yaive yeavhareji shanduko mune yakanakisa-yakagadziriswa kuona acuity (BCVA) mamakisi (chiyero cheyakanakisa chiratidzo chinogona kuwanikwa nemunhu kana achiverenga mabhii pane yeziso chati, kusanganisira nekururamisa senge magirazi) kubva pakutanga pagore. 5. Nokuda kwekuongorora kwekupedzisira kwehutano hwekupedzisira, varwere veKSI-301 mumapoka ose matatu (dosed ose 3, 1 kana 301 mwedzi) vakabatanidzwa pamwe chete uye BCVA yavo yakafananidzwa seboka neboka reflibercept (yakatorwa mwedzi yose ye3) .
Mhedzisiro yacho inoratidza kuti, kunyangwe KSI-301 yakaratidza kusimba kwakasimba uye yakachengeteka uye yakatenderwa zvakanaka, haina kusangana neiyo yekutanga efficacy endpoint yekuratidza isiri-yakaderera yekuona acuity kuwana kune zvidzidzo zvakadhamurwa pamarejimeni akawedzerwa zvichienzaniswa neaflibercept inopihwa masvondo masere ega ega.
Ongororo yakagara yatsanangurwa yechipiri pagore 1 yekuongorora kusimba kwakaratidza 59% yevarwere muKSI-301 ruoko vakawana mwedzi mishanu dosing nekuona acuity kuwana uye kuvandudzwa kweanatomic kuenzaniswa neboka rose reflibercept.
KSI-301 yaive yakachengeteka uye yakatenderwa zvakanaka muchidzidzo, isina masaini matsva ekuchengetedza akaonekwa.
ZVOKUBVA MUNYAYA INO:
- Mhedziso yekutanga yechidzidzo yaive yeavhareji shanduko mune yakanakisa-yakagadziriswa kuona acuity (BCVA) mamakisi (chiyero cheyakanyanya kuona munhu anogona kuwana kana achiverenga mavara pane yeziso chati, kusanganisira nekururamisa senge magirazi) kubva pakutanga pagore. 1.
- Nekuongororwa kweiyo yekutanga efficacy endpoint, varwere veKSI-301 mumapoka ese matatu (yakatorwa yega yega 3, 4 kana 5 mwedzi) yakaunganidzwa pamwe chete uye BCVA yavo yakafananidzwa seboka kune aflibercept boka (yakadhawa mwedzi miviri yega yega).
- Nekuda kweizvozvo, varwere muboka reKSI-301 havana kugamuchira dosing kakawanda kupfuura mwedzi yese ye3 chero nguva muchidzidzo mushure mechikamu chekurodha.
