Molekane oa BioArctic AB Eisai o phatlalalitse kajeno hore sengoloa se mabapi le liphetho tsa nako e telele tsa bophelo bo botle ba lipatlisiso tsa anti-amyloid-beta (Aβ) protofibril antibody lecanemab (BAN2401) ho batho ba phelang le lefu la Alzheimer la pele (AD), ba sebelisa mohlala oa mafu, se phatlalalitsoe ho koranta e hlahlobiloeng ke lithaka Neurology and Therapy. Papisong ena, kalafo ea lecanemab e hakanngoa hore e liehisa sekhahla sa tsoelo-pele ea mafu, ho boloka bakuli ba phekoloang nako e telele maemong a pele a lefu lena.
Sengoliloeng sena se shebana le liphetho tsa nako e telele tsa kliniki bakeng sa batho ba phelang le AD ea pele (MCI) le AD e bobebe ba nang le lefu la amyloid, ba bapisa lecanemab hammoho le maemo a tlhokomelo (SoC) khahlano le SoC feela (acetylcholinesterase inhibitor kapa memantine. ). Papiso e thehiloe ho bakuli ba phekoloang ho fihlela ba fihla boemong bo itekanetseng ba AD. Moetso oa ketsiso ea lefu (AD ACE model1) o ipapisitse le liphetho tsa teko ea bongaka ea Phase 2b e hlahlobang katleho le polokeho ea lecanemab, le ho tsoa ho ADNI (Alzheimer's Disease Neuroimaging Initiative) liphetho tsa boithuto.
Kalafo ea Lecanemab e hakanngoa hore e liehisa sekhahla sa tsoelo-pele ea mafu, e leng se bakang nako e telele ea MCI ka lebaka la AD le 'dementia' e bobebe ea AD mme e khutsufatsa nako ea 'dementia' e itekanetseng le e matla. Moetsong nako e bolelang ho fetela ho 'dementia' e bonolo, e itekanetseng, le e matla ea AD e ne e le telele ho bakuli ba sehlopheng sa kalafo ea lecanemab ho feta bakuli ba sehlopha sa SoC ka lilemo tse 2.51, 3.13 le 2.34, ka ho latellana. Moetso o boetse o boletse esale pele monyetla o tlase oa nako ea bophelo oa ho amoheloa tlhokomelong ea setheo ka kalafo ea lecanemab.
"Liphetho tsa papiso e entsoeng ke Eisai li bonts'a boleng bo ka bang teng kliniking ba lecanemab bakeng sa bakuli ba nang le AD ea pele le kamoo e ka liehisang sekhahla sa tsoelo-pele ea mafu, ho lieha ho fetela ho 'dementia' ea AD ka lilemo tse 'maloa le ho fokotsa tlhoko ea tlhokomelo e hlophisitsoeng. Litlhahlobo tse kang tsena li bohlokoa ho utloisisa litlamorao tse ka bang teng tsa nako e telele bakeng sa mokuli, malapa le sechaba tse fanoang ke kalafo ea lecanemab ho feta se ka bonoang litekong tsa bongaka. Sephetho sa thuto ea Clarity AD Phase 3 e tla ba ea bohlokoa ho tsoela pele ho ntlafatsa mofuta ona, 'me re lebelletse liphetho tsa mantlha hamorao selemong sena, "ho boletse Gunilla Osswald, CEO oa BioArctic.
Lecanemab e fuoe mabitso a Breakthrough Therapy le Fast Track ke US Food and Drug Administration (FDA) ka Phuptjane le Tšitoe 2021, ka ho latellana. Eisai o lebelletse ho phethela tlhahiso ea lecanemab ea Kopo ea License ea Biologics bakeng sa kalafo ea AD pele ho FDA tlas'a tsela e potlakileng ea tumello kotareng ea bobeli ea 2022. Ho feta moo, ho lebeletsoe hore ho baloe tlhahlobo ea Phase 3 ea netefatso ea Clarity AD qetellong ea Loetse. 2022. Eisai e qalile ho romela ho Setsi sa Meriana le Lisebelisoa tsa Kalafo (PMDA) ea data ea kopo ea lecanemab tlas'a tsamaiso ea tlhahlobo ea pele ho Japane ka Hlakubele 2022.
Phatlalatso ena e bua ka ts'ebeliso ea lipatlisiso tsa moemeli nts'etsopele mme ha ea rereloa ho fana ka liqeto mabapi le katleho kapa polokeho. Ha ho na tiiso ea hore ts'ebeliso efe kapa efe ea lipatlisiso ea sehlahisoa se joalo e tla phethela ka katleho nts'etsopele ea bongaka kapa e fumane tumello ho bolaoli ba bophelo bo botle.
