Warqaddii cilmi-baarista ee dhowaanta[1], oo cinwaan looga dhigay "Baaxadda Caabuqa Cagaarshowga B ee Joogtada ah ee Mareykanka" oo la daabacay Juun 2020, ayaa muujisay qiyaasta guud ee baahsanaanta fayraska cagaarshow B ee dabadheeraaday (HBV) ee gudaha Mareykanka 1.59 milyan bukaan (kala duwan 1.25-2.49 milyan). Ururka Caafimaadka Adduunka (WHO) iyo Waaxda Caafimaadka iyo Adeegyada Aadanaha ee Mareykanka (DHHS) labaduba waxay si cad u qeexeen qorshooyinka ciribtirka cagaarshowga.
Daraasada ASC22 Wajiga IIb (ClinicalTrials.gov Identifier: NCT04465890) waa randomized, hal-indhole, placebo-control, multi-center trial clinical in China kaas oo qiimeeya waxtarka iyo badbaadada bukaanada 149 CHB ee daaweynta 24-usbuuc ee 1 mg / kg ama 2.5 mg/kg ASC22 ama placebo u dhigma oo la siiyo hal mar labadii usbuucba mar (Q2W) marka lagu daro NA-yada. Natiijooyinka ku meel gaadhka ah, ee loo aqbalay soo jeedinta afka ee Kalfadhiga Jebinta Dambe ee Kulanka Beerka 2021 ee Ururka Maraykanka ee Daraasaadka Cudurada Beerka (AASLD) ayaa muujiyay in bukaanada leh heerka aasaasiga ah cagaarshowga B dusha antigen (HBsAg) heerka ≤ 500 IU / mL, qiyaastii 19% (3/16) bukaanada kooxda daawaynta ku jira waxay heleen khasaare HBsAg ah oo aan la barbar dhigin maaddo la gaadhay HBsAg lumin kooxda placebo iyo dib u soo celin ma jirto ka dib qiyaasta ugu dambeysa ee ASC22, taasoo muujinaysa daaweynta shaqeynta HBV.
Wajiga IIa iyo IIb daraasaadka kiliinikada ee ASC22 ee daawaynta shaqaynaysa HBV ayaa loo doortay in lagu daro "Ugu Wanaagsan Kulanka Beerka Kooban" ee 2021 by guddiga dib u eegista AASLD. Ku darida noocaan ah waa sharaf gaar ah waxayna muujineysaa heerka sare ee guddiga dib u eegista AASLD ay tixgeliyeen cilmi baarista Ascletis ee daaweynta shaqeynta CHB.
Ascletis waxay ku dhawaaqday inay heshay shati caalami ah oo gaar ah laga bilaabo 8 Noofambar, 2021 Suzhou Alphamab si ay u horumariso oo ay ganacsi uga dhigto ASC22 dhammaan cudurada fayraska oo ay ku jiraan cagaarshowga B. Ascletis buugaagta adduunka oo dhan iibka ASC22 ee dhammaan cudurada fayraska.
ASC22 waa heerka ugu horumarsan ee daaweynta immunotherapy ee aduunka ee daaweynta shaqeynta CHB, ie luminta HBsAg, iyada oo la xirayo dariiqa PD-1/PD-L1.
MAXAA LAGU QAADAYAA MAQAALKAN:
- Interim results, which were accepted for oral presentation in Late Breaking Session at The Liver Meeting® 2021 by the American Association for the Study of Liver Diseases (AASLD) showed that in patients with the baseline hepatitis B surface antigen (HBsAg) level ≤ 500 IU/mL, approximately 19% (3/16) of patients in the treatment group obtained HBsAg loss versus no subject achieved HBsAg loss in the placebo group and no rebound after the last dosing of ASC22, indicating HBV functional cure.
- NCT04465890) is a randomized, single-blind, placebo-controlled, multi-center clinical trial in China which evaluates the efficacy and safety of 149 CHB patients for 24-week treatment of 1 mg/kg or 2.
- Ascletis announced it had obtained a global and exclusive license as of 8 November, 2021 from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B.
