1-yil iyun oyida chop etilgan “Qo‘shma Shtatlarda surunkali gepatit B virusi infektsiyasining tarqalishi” nomli so‘nggi tadqiqot maqolasi [2020] AQShda surunkali gepatit B virusi (HBV) infektsiyasining umumiy taxminiy tarqalishini 1.59 million bemorni ko‘rsatdi (diapazon). 1.25–2.49 million). Jahon sog'liqni saqlash tashkiloti (JSST) va AQSh Sog'liqni saqlash va aholiga xizmat ko'rsatish departamenti (DHHS) gepatitni yo'q qilish bo'yicha rasmiy rejalarga ega.
ASC22 faza IIb tadqiqoti (ClinicalTrials.gov identifikatori: NCT04465890) Xitoyda randomizatsiyalangan, bitta ko'r, platsebo-nazorat qilinadigan, ko'p markazli klinik sinov bo'lib, u 149 CHB bemorining 24 haftalik davolash uchun 1 mg / 2.5 haftalik davolash uchun samaradorligi va xavfsizligini baholaydi. kg yoki 22 mg/kg ASC2 yoki mos keladigan platsebo har ikki haftada bir marta (Q2021W) NA bilan birgalikda beriladi. Amerika Jigar kasalliklarini o'rganish assotsiatsiyasi (AASLD) tomonidan The Liver Meeting® 500 kechki sessiyasida og'zaki ma'ruza qilish uchun qabul qilingan oraliq natijalar shuni ko'rsatdiki, gepatit B sirt antigenining (HBsAg) bazaviy darajasi ≤ 19 IU bo'lgan bemorlarda. /ml, davolash guruhidagi bemorlarning taxminan 3% (16/22) HBsAg yo'qolgan, platsebo guruhida hech bir sub'ektda HBsAg yo'qolmagan va ASCXNUMX ning oxirgi dozasidan keyin rebound bo'lmagan, bu HBV funktsional davolanishini ko'rsatadi.
HBV funktsional davolash uchun ASC22 ning IIa va IIb fazali klinik tadqiqotlari AASLD ko'rib chiqish qo'mitasi tomonidan 2021 yilda "Jigar yig'ilishining eng yaxshi xulosasi" ro'yxatiga kiritish uchun tanlangan. Bunday qo'shilish o'ziga xos sharafdir va AASLD ko'rib chiqish qo'mitasi Ascletisning CHB funktsional davolash bo'yicha tadqiqotlariga yuqori darajada munosabat bildiradi.
Ascletis 8-yil 2021-noyabrda Suzhou Alphamab kompaniyasidan ASC22-ni barcha virusli kasalliklar, shu jumladan Gepatit B uchun ishlab chiqish va tijoratlashtirish uchun global va eksklyuziv litsenziya olganini e'lon qildi. Ascletis kitoblarini butun virusli kasalliklarning ASC22 uchun global miqyosda sotish.
ASC22 - bu PD-1/PD-L1 yo'lini blokirovka qilish orqali CHB funktsional davolash, ya'ni HBsAg yo'qolishi uchun dunyodagi eng ilg'or klinik bosqichli immunoterapiya.
USHBU MAQOLADAN NIMA OLISH KERAK:
- 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.
