Ukulibazisa ukuqhubela phambili kwi-Alzheimer's dementia

A BAMBA isiKhululo sasimahla 5 | eTurboNews | eTN
IAvatar kaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

Umlingani we-BioArctic AB u-Eisai ubhengeze namhlanje ukuba inqaku malunga neziphumo zezempilo zexesha elide zophando lwe-anti-amyloid-beta (Aβ) i-protofibril antibody lecanemab (BAN2401) kubantu abaphila nesifo se-Alzheimer's (AD), usebenzisa imodeli yesifo, yapapashwa ijenali ephononongwe ntanga Neurology and Therapy. Kolu kulinganisa, unyango lwe-lecanemab luqikelelwa ukuba lucothisa isantya sokuqhubekeka kwesifo, ukugcina izigulana ezinyangwayo ixesha elide kumanqanaba angaphambili esi sifo.

Eli nqaku ligxininise kwiziphumo zeklinikhi zexesha elide kubantu abaphila ne-AD yokuqala (i-mild cognitive impairment (MCI) kunye ne-AD epholileyo) abane-amyloid pathology, bethelekisa i-lecanemab kunye nomgangatho wokunyamekela (i-SoC) ngokuchasene ne-SoC yodwa (i-acetylcholinesterase inhibitor okanye i-memantine ). Ukulinganisa kusekelwe kwizigulane eziphathwayo de zifike kwinqanaba le-AD eliphakathi. Imodeli yokulinganisa isifo (i-AD ACE model1) isekelwe kwiziphumo zeSigaba se-2b solingo lwekliniki oluvavanya ukusebenza kunye nokhuseleko lwe-lecanemab, kunye ne-ADNI (i-Alzheimer's Disease Neuroimaging Initiative) iziphumo zophononongo.

Unyango lwe-Lecanemab lwaqikelelwa ukuba lucothisa isantya sokuqhubekeka kwesifo, okukhokelela kubude bexesha elongeziweyo le-MCI ngenxa ye-AD kunye ne-AD dementia ethambileyo kwaye yanciphisa ubude bedementia ephakathi kunye neqatha ye-AD. Kulo mzekelo ixesha elithetha ukuba liqhubela phambili kwi-AD dementia epholileyo, ephakathi, kwaye enzima kakhulu kwizigulane kwiqela le-lecanemab ephathwayo kunezigulane kwiqela le-SoC ngeminyaka eyi-2.51, i-3.13 kunye ne-2.34, ngokulandelanayo. Imodeli iphinde yaxela kwangaphambili amathuba aphantsi obomi bokwamkelwa kukhathalelo lweziko ngonyango lwe-lecanemab.

“Iziphumo zokulinganisa okwenziwa ngu-Eisai zibonisa ixabiso lekliniki elinokubakho le-lecanemab kwizigulana ezine-AD yokuqala kunye nendlela enokucothisa ngayo izinga lokuqhubekela phambili kwesifo, ukulibaziseka kokuqhubela phambili kwi-AD dementia kwiminyaka eliqela kunye nokunciphisa imfuno yokhathalelo kwiziko. Uhlalutyo olufana nolu lubalulekile ukuqonda iziphumo ezinokubakho zexesha elide kwisigulane, iintsapho kunye noluntu olunikezelwa ngonyango lwe-lecanemab ngaphaya koko kunokubonwa kulingo lwezonyango. Isiphumo sophononongo lweSigaba sesi-3 se-Clarity AD siya kubaluleka ukuqhubela phambili nokucokisa le modeli, kwaye sijonge phambili kwiziphumo eziphambili kulo nyaka, utshilo uGunilla Osswald, i-CEO ye-BioArctic.

I-Lecanemab yanikwa iBreakthrough Therapy kunye nokubizwa kwe-Fast Track yi-US Food and Drug Administration (FDA) ngoJuni nangoDisemba ka-2021, ngokulandelelanayo. U-Eisai ulindele ukugqibezela ukuhanjiswa kwe-lecanemab eqengqelekayo yeSicelo seLayisensi ye-Biologics kunyango lwe-AD kwangoko kwi-FDA phantsi kwendlela yolwamkelo olukhawulezileyo kwikota yesibini ka-2022. Ukongeza, ukufundwa kweSigaba sesi-3 sokuqinisekisa ulingo lwezonyango lwe-AD lulindeleke ekupheleni kukaSeptemba. 2022. U-Eisai uqalise ukungeniswa kwi-Arhente ye-Pharmaceuticals and Medical Devices Agency (PMDA) yedatha yesicelo se-lecanemab phantsi kwenkqubo yokubonisana novavanyo lwangaphambili eJapan ngoMatshi ka-2022.

Olu khululo luxoxa ngokusetyenziswa kophando lwearhente kuphuhliso kwaye ayenzelwanga ukuhambisa izigqibo malunga nokusebenza ngempumelelo okanye ukhuseleko. Akukho siqinisekiso sokuba nakuphi na ukusetyenziswa kophando kwemveliso enjalo kuya kuthi kulugqibe ngempumelelo uphuhliso lweklinikhi okanye ufumane ukuvunywa kwegunya lezempilo.

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IAvatar kaLinda Hohnholz

Linda Hohnholz

Umhleli oyintloko we eTurboNews esekwe kwi-eTN HQ.

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