Makalah riset anyar [1], kanthi irah-irahan "Prevalensi Infeksi Virus Hepatitis B Kronis ing Amerika Serikat" sing diterbitake ing Juni 2020, nuduhake prevalensi sakabèhé kanggo infèksi virus hepatitis B kronis (HBV) ing AS kanthi 1.59 yuta pasien (kisaran) 1.25–2.49 yuta). Organisasi Kesehatan Dunia (WHO) lan Departemen Kesehatan lan Layanan Manungsa AS (DHHS) wis ngumumake rencana eliminasi hepatitis resmi.
ASC22 Phase IIb study (ClinicalTrials.gov Identifier: NCT04465890) minangka uji klinis acak, siji-buta, kontrol plasebo, multi-pusat ing China sing ngevaluasi khasiat lan safety 149 pasien CHB kanggo perawatan 24 minggu 1 mg / kg utawa 2.5 mg / kg ASC22 utawa plasebo sing cocog diwenehi saben rong minggu (Q2W) kanthi kombinasi NAs. Asil interim, sing ditampa kanggo presentasi lisan ing Late Breaking Session ing The Liver Meeting® 2021 dening American Association for the Study of Liver Diseases (AASLD) nuduhake yen ing pasien kanthi tingkat antigen permukaan hepatitis B baseline (HBsAg) ≤ 500 IU / mL, kira-kira 19% (3/16) pasien ing grup perawatan entuk mundhut HBsAg versus ora ana subyek sing entuk mundhut HBsAg ing klompok plasebo lan ora ana rebound sawise dosis pungkasan ASC22, sing nuduhake penyembuhan fungsional HBV.
Pasinaon klinis Fase IIa lan IIb ASC22 kanggo obat fungsional HBV dipilih kanggo dilebokake ing "Ringkesan Rapat Liver Paling Apik" ing 2021 dening panitia tinjauan AASLD. Gawan kasebut minangka pakurmatan tunggal lan nuduhake tingkat dhuwur sing panitia review AASLD nganggep riset Ascletis ing perawatan fungsional CHB.
Ascletis ngumumake wis entuk lisensi global lan eksklusif wiwit 8 November 2021 saka Suzhou Alphamab kanggo ngembangake lan komersialisasi ASC22 kanggo kabeh penyakit virus kalebu Hepatitis B. Penjualan buku Ascletis sacara global kanggo ASC22 kabeh penyakit virus.
ASC22 minangka imunoterapi tahap klinis paling maju ing donya kanggo tamba fungsional CHB, yaiku mundhut HBsAg, liwat pamblokiran jalur PD-1/PD-L1.
APA sing kudu dijupuk saka ARTIKEL INI:
- 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.
