The expansion cohort is a randomized, single-blind, placebo-controlled, multicenter clinical trial (ClinicalTrials.gov: NCT04465890) planned to enroll approximately 50 patients with chronic hepatitis B and baseline hepatitis B surface antigen (HBsAg) ≤ 100 IU/mL. patient. Patients received 1.0 mg/kg ASC22 or placebo (approximately 4:1 ratio) every two weeks (week 2) for 24 weeks of treatment plus 24 weeks of follow-up. All patients in the ASC22 and placebo cohorts received nucleoside analogs (NA) as background therapy. Second quarter of 2023, Song Dynasty Enrollment of 49 CHB patients was successfully completed, including 40 patients in the ASC22 cohort and 9 patients in the placebo cohort.
An interim analysis was conducted when approximately 50% of enrolled patients completed 24 weeks of treatment with ASC22 or placebo. The interim analysis included 25 patients who completed 24 weeks of treatment (19 patients in the ASC22 cohort and 6 patients in the placebo cohort). Topline results showed that in the ASC22 cohort, 4 patients (4/19, 21.1%) achieved HBsAg loss at the end of 24 weeks of treatment. In contrast, no patients in the placebo group (0/6, 0%) achieved HBsAg loss at the end of 24 weeks of treatment. ASC22 was generally safe and well tolerated.Most ASC22 drug-related adverse reactions The effect is Level 1 or 2.
Chronic hepatitis B remains a significant unmet medical need globally, with approximately 86 million people living with chronic hepatitis B.
“While conducting a Phase IIb clinical study of ASC22 (Envafolimab) as monotherapy for the treatment of CHB patients with baseline HBsAg ≤ 100 IU/mL, we are also working with global partners to discuss combination therapy collaborations to achieve higher functional cure of HBV rate.” said the doctor.
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(1)Lim JK, Nguyen MH, Kim WR, et al. Prevalence of chronic hepatitis B virus infection in the United States (J). American Journal of Gastroenterology 2020, 115(9): 1429-38. |
about Song Dynasty
Song Dynasty It is an innovative R&D-driven biotechnology company listed on the Science and Technology Innovation Board. Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and proven track record, Song Dynasty A global perspective focuses on three therapeutic areas with unmet medical needs: viral diseases, non-alcoholic steatohepatitis (NASH), and oncology. Through excellent execution, Song Dynasty Rapidly advancing its drug pipeline, aiming to stay ahead of global competition. So far, Song Dynasty It has multiple drug candidates in its pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).
For more information, please visit www.ascletis.com.
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source Ascletis Pharmaceuticals