Investigational New Drug Application for Chronic Hepatitis B
The recent research paper, titled “Prevalence of Chronic Hepatitis B Virus Infection in the United States” published in June 2020, showed an overall estimated prevalence for chronic hepatitis B virus (HBV) infection in the U.S. of 1.59 million patients (range 1.25–2.49 million). Both the World Health Organization (WHO) and U.S. Department of Health and Human Services (DHHS) have articulated formal hepatitis elimination plans.
ASC22 Phase IIb study (ClinicalTrials.gov Identifier: 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 2.5 mg/kg ASC22 or matching placebo given once every two weeks (Q2W) in combination with NAs. 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.
Phase IIa and IIb clinical studies of ASC22 for HBV functional cure were selected for inclusion in the “Best of The Liver Meeting’s Summary” in 2021 by AASLD review committee. Such inclusion is a singular honor and indicates the high level with which the AASLD review committee regards Ascletis’ research in CHB functional cure.
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. Ascletis books sales globally for ASC22 of all viral diseases.
ASC22 is the most advanced clinical stage immunotherapy in the world for CHB functional cure, i.e. HBsAg loss, through blocking PD-1/PD-L1 pathway.