Pampiri ea morao-rao ea lipatlisiso[1], e nang le sehlooho se reng "Ho ata ha Ts'oaetso ea Kokoana ea Hepatitis B e sa Feleng United States" e phatlalalitsoeng ka Phuptjane 2020, e bonts'itse sekhahla se hakanyetsoang sa ts'oaetso ea vaerase e sa foleng ea hepatitis B (HBV) US ho bakuli ba limilione tse 1.59 (mefuta e fapaneng. 1.25-2.49 milione). Ka bobeli Mokhatlo oa Lefatše oa Bophelo (WHO) le Lefapha la Bophelo bo Botle le Litšebeletso tsa Botho la United States (DHHS) li hlahisitse merero e hlophisitsoeng ea ho felisa lefu la sebete.
Thuto ea ASC22 Phase IIb (ClinicalTrials.gov Identifier: NCT04465890) ke teko ea bongaka e laoloang ka mokhoa o sa reroang, e sa boneng, e laoloang ke sebaka se le seng naheng ea Chaena e hlahlobang katleho le polokeho ea bakuli ba 149 CHB bakeng sa kalafo ea libeke tse 24 ea 1 mg/ lik'hilograma kapa 2.5 mg/kg ASC22 kapa placebo e tšoanang e fanoang hang ka libeke tse ling le tse ling tse peli (Q2W) hammoho le NA. Liphetho tsa nakoana, tse ileng tsa amoheloa bakeng sa nehelano ea molomo ho Late Breaking Session ho The Liver Meeting® 2021 ke American Association for the Study of Liver Diseases (AASLD) li bonts'itse hore ho bakuli ba nang le boemo ba mantlha ba hepatitis B surface antigen (HBsAg) ≤ 500 IU. /mL, hoo e ka bang 19% (3/16) ea bakuli ba sehlopheng sa kalafo ba fumane tahlehelo ea HBsAg khahlano le tahlehelo ea HBsAg e fihletsoeng sehlopheng sa placebo mme ha ho na ho khutla ka mor'a dosing ea ho qetela ea ASC22, e bonts'ang pheko e sebetsang ea HBV.
Lithuto tsa kliniki tsa Phase IIa le IIb tsa ASC22 bakeng sa pheko e sebetsang ea HBV li ile tsa khetheloa ho kenyelletsoa ho "Best of The Liver Meeting's Summary" ka 2021 ke komiti ea tlhahlobo ea AASLD. Kenyelletso e joalo ke tlotla e le 'ngoe mme e bonts'a boemo bo holimo boo komiti ea tlhahlobo ea AASLD e nkang lipatlisiso tsa Ascletis ho pheko e sebetsang ea CHB.
Ascletis e phatlalalitse hore e fumane laesense ea lefats'e le e ikhethileng ho tloha ka la 8 Pulungoana, 2021 ho tsoa ho Suzhou Alphamab ho nts'etsapele le ho rekisa ASC22 bakeng sa mafu ohle a vaerase ho kenyeletsoa thekiso ea libuka tsa Hepatitis B. Ascletis lefatšeng ka bophara bakeng sa ASC22 ea mafu 'ohle a vaerase.
ASC22 ke mohato o tsoetseng pele ka ho fetesisa oa immunotherapy lefatšeng bakeng sa pheko e sebetsang ea CHB, ke hore, tahlehelo ea HBsAg, ka ho thibela tsela ea PD-1/PD-L1.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- 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.
