Kafukufuku Watsopano Wachipatala Wavomerezedwa Kuti Azichiza Matenda a Parkinson's Early-Stage

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Written by Linda Hohnholz

Pa Januware 13, 2022, Green Valley (Shanghai) Pharmaceuticals Co., Ltd. idalandira kalatayo kuchokera ku US Food and Drug Administration (FDA) pa Investigational New Drug (IND) yofunsira mayeso azachipatala apadziko lonse lapansi. wa Oligomannate (wogulitsidwa ngati "GV-971"), mankhwala opangidwa ndi kampani ochizira matenda a Alzheimer's (AD). Kalatayo inasonyeza kuti "Study May Proceed" ndi kafukufuku wachipatala omwe akufunsidwa pochiza odwala omwe ali ndi matenda a Parkinson's (PD). Tsiku lomaliza la IND ndi Disembala 16, 2021.

Monga matenda achiwiri odziwika bwino a neurodegenerative pambuyo pa AD, ngakhale kuti matenda a PD sadziwika bwino, amakhulupirira kuti matendawa amagwirizanitsidwa ndi α-synuclein aggregation, neuroinflammation, kupsinjika kwa okosijeni, ndi kusokonezeka kwa mitochondrial. M'zaka zaposachedwa, umboni wochulukirachulukira wawonetsa kuti gut microbiota imagwirizana kwambiri ndi zomwe zimachitika komanso chitukuko cha PD.

Pokhala mankhwala oyamba padziko lonse lapansi a AD omwe amalowera m'matumbo aubongo, GV-971 imachepetsa kutupa kwapakati ndi kotumphukira1 pokonzanso matumbo a microbiota ndikuletsa kusakwanira bwino kwa metabolites yochokera m'matumbo a microbiota. Kutengera zomwe zapezedwa, gulu lofufuza ku Green Valley Research Institute lidachita kafukufuku wa GV-971 pa PD potengera njira yodziwika bwino ya matenda a neurodegenerative ndipo idapeza kuti mankhwalawa amatha kuwongolera matumbo a microbiota dysbiosis, kupondereza α-synuclein. kuphatikizika m'matumbo ndi muubongo, kumachepetsa kutukusira kwa neuroinflammation, kuteteza ma dopaminergic neurons, ndikuwongolera zizindikiro zamagalimoto ndi zosakhala zamagalimoto.

Kuyesa kwachipatala kwapadziko lonse lapansi kwapakati pa gawo II kudzakhala sabata la 36, ​​lapakati, lachisawawa, losawona bwino, loyang'aniridwa ndi placebo, ndikutsatiridwa ndi nthawi yowonjezera label ya 36-masabata. Mlanduwu ukukonzekera kulembetsa odwala 300 omwe ali ndi PD yoyambirira, ndipo adzachitidwa m'zipatala za 30 ku North America ndi Asia Pacific dera kuti aone momwe GV-971 imathandizira komanso chitetezo cha GV-XNUMX pochiza PD yoyambirira.

Pa Novembara 2, 2019, National Medical Products Administration yaku China idavomereza GV-971 kuti "ichiza AD pang'onopang'ono mpaka pang'onopang'ono ndikuwongolera magwiridwe antchito anzeru", pambuyo powunikira mwachangu mankhwalawa. Kuyesa kwa gawo-III kwa GV-971 ku China kunachitika m'zipatala 34 za Tier-1 m'dziko lonselo mwa odwala 818 omwe ali ndi AD yocheperako mpaka pang'ono. Zotsatira za mayesero a masabata a 36 zinasonyeza kuti GV-971 inasintha kwambiri ntchito yachidziwitso kwa odwala AD omwe ali ochepa kwambiri, ndipo anali otetezeka komanso olekerera ndi zotsatira zofanana ndi placebo1.

Mu Epulo 2020, pempho la mayeso azachipatala a GV-971 a GV-10 padziko lonse lapansi adavomerezedwa ndi US FDA. Mlandu wapadziko lonse lapansi wavomerezedwa ndi mabungwe olamulira m'maiko 154 ndi zigawo, kuphatikiza , Canada, China, Australia, France, Czech ndi ena. Pakalipano, zipatala za 949 m'mayikowa zakhala zikugwiritsidwa ntchito, ndipo odwala 292 adayesedwa ndi odwala 2025 osasintha. Mlanduwu ukuyembekezeka kutha pofika chaka cha XNUMX, kenako ndikutumiza padziko lonse lapansi kugwiritsa ntchito mankhwala atsopano.

Chiyambireni kukhazikitsidwa kwake, GV-971 yaphatikizidwa motsatizana ndi malangizo azachipatala ovomerezeka aku China ochizira matenda. Izi zikuphatikiza Malangizo a Kuzindikira ndi Kuchiza matenda a Alzheimer's (Kusindikiza kwa 2020)2 lofalitsidwa ndi National Health Commission General ofesi yomwe imalimbikitsa GV-971 yochizira AD yocheperako mpaka pang'ono, Consensus Expert on the Management of Post-Stroke Cognitive Impairment 20213, Katswiri wa Consensus pa Nutritional Intervention for Brain Health in Alzheimer's Disease4, Malangizo a Kuzindikira ndi Kuchiza matenda amisala (Kusindikiza kwa 2020)5, White Paper on the Standardized Construction of Diagnosis and Treatment Centers for Cognitive Disorders6, ndi Malangizo aku China a Prevention and Treatment of Elderly Dementia lofalitsidwa ndi Chinese Society of Neurology pansi pa Chinese Medical Association mu Disembala 2021, yomwe idalemba GV-971 ngati mankhwala ovomerezeka a Gulu A okhala ndi umboni wa Level-1 wochizira AD. Pa Disembala 3, 2021, GV-971 idaphatikizidwa mwalamulo pamndandanda wamankhwala aku China Obwezera Kwanthawi yoyamba.

Monga matenda a neurodegenerative, zizindikiro zazikulu zachipatala za PD zimaphatikizapo kugwedezeka kwa kupuma, bradykinesia, myotonia ndi postural gait chisokonezo, zomwe zikhoza kutsatiridwa ndi zizindikiro zopanda magalimoto monga kuvutika maganizo, kudzimbidwa ndi kugona. Onse pamodzi, amasokoneza moyo wa odwala komanso momwe amagwirira ntchito tsiku ndi tsiku. Ziwerengero zikuwonetsa kuti pali odwala pafupifupi 10 miliyoni a PD padziko lonse9, kuphatikiza 3 miliyoni ku China, ndipo kuchuluka kwa anthu opitilira zaka 65 ndi 1.7% 10. Ngakhale kuti chiwerengero cha anthu padziko lonse chikukula, chiwerengero cha odwala PD chidzapitirira kukula.

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Avatar ya Linda Hohnholz

Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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