Investigational New Drug Application for Chronic Hepatitis B

Written by mkonzi

Pali odwala pafupifupi 1.59 miliyoni a matenda a chiwindi a B (CHB) ku US Ascletis Pharma Inc. yalengeza lero kuvomereza kwa Investigational New Drug (IND) ndi US Food and Drug Administration (FDA) ndikuyambitsa chitukuko cha padziko lonse cha ASC22 (Envafolimab) , kalasi yoyamba, yoyendetsedwa pang'onopang'ono ya PD-L1 kuti ichiritse matenda amtundu wa B (CHB).

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Pepala lofufuzira laposachedwa[1], lotchedwa "Kuchuluka kwa Matenda a Chiwindi Chachiwindi B ku United States" lofalitsidwa mu June 2020, likuwonetsa kufalikira kwa matenda osachiritsika a hepatitis B (HBV) ku US mwa odwala 1.59 miliyoni (osiyanasiyana. 1.25-2.49 miliyoni). Bungwe la World Health Organization (WHO) ndi US Department of Health and Human Services (DHHS) afotokoza ndondomeko zothetsa matenda a chiwindi.

Kafukufuku wa ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) ndi mayeso osasinthika, osawona, osawona, oyendetsedwa ndi placebo, opezeka m'malo ambiri ku China omwe amayesa mphamvu ndi chitetezo cha odwala 149 CHB pa chithandizo cha milungu 24 cha 1 mg/ kg kapena 2.5 mg/kg ASC22 kapena placebo yofananira yoperekedwa kamodzi milungu iwiri iliyonse (Q2W) kuphatikiza ndi NA. Zotsatira zanthawi yochepa, zomwe zidavomerezedwa kuti ziwonetsedwe pakamwa mu Late Breaking Session ku The Liver Meeting® 2021 ndi American Association for the Study of Liver Diseases (AASLD) zidawonetsa kuti mwa odwala omwe ali ndi gawo loyambira la hepatitis B pamwamba antigen (HBsAg) ≤ 500 IU. /mL, pafupifupi 19% (3/16) ya odwala omwe ali m'gulu lachipatala adalandira kutayika kwa HBsAg motsutsana ndi palibe amene adapeza HBsAg kutayika m'gulu la placebo ndipo palibe kubwereza pambuyo pa mlingo womaliza wa ASC22, kusonyeza kuchiritsa kwa HBV.

Maphunziro achipatala a Phase IIa ndi IIb a ASC22 a machiritso a HBV adasankhidwa kuti aphatikizidwe mu "Best of The Liver Meeting's Summary" mu 2021 ndi komiti yowunikira ya AASLD. Kuphatikizika koteroko ndi ulemu umodzi ndipo kumasonyeza mlingo wapamwamba umene komiti yowunikira ya AASLD imaganizira kafukufuku wa Ascletis mu chithandizo chamankhwala cha CHB.

Ascletis idalengeza kuti yapeza chilolezo chapadziko lonse lapansi komanso chapadera kuyambira pa 8 Novembara, 2021 kuchokera ku Suzhou Alphamab kuti ipange ndi kugulitsa ASC22 yamatenda onse obwera chifukwa cha ma virus kuphatikiza Hepatitis B. Ascletis mabuku ogulitsa padziko lonse lapansi chifukwa cha ASC22 yamatenda onse obwera chifukwa cha ma virus.

ASC22 ndiye njira yapamwamba kwambiri padziko lonse lapansi yochizira matenda a CHB, mwachitsanzo, kutayika kwa HBsAg, kudzera kutsekereza njira ya PD-1/PD-L1.

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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