Ascletis Announces Positive Interim Data from Phase IIb Expansion Cohort of ASC22 (Envafolimab) to Functionally Cure Chronic Hepatitis B

Hangzhou and Shaoxing, China, September. 28, 2023 /PRNewswire/ — Ascletis Pharmaceuticals Limited (SEHK: 1672, “Ascletis”) today announced the Phase IIb expansion cohort of the subcutaneous PD-L1 antibody ASC22 (Envafolimab) for functional cure ( Positive interim data from the “expansion cohort”) chronic hepatitis B (CHB).

The expansion cohort is a randomized, single-blind, placebo-controlled, multicenter clinical trial ( 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. In the second quarter of 2023, Ascletis successfully completed the enrollment of 49 patients with chronic hepatitis B, 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. China 1.59 million people in the United States are infected with hepatitis B virus (HBV)(1).

“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. Wu Jinzifounder, chairman and CEO of Ascletis.

(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 Songli

Ascletis is an innovative R&D-driven biotech company listed on the 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, Ascletis focuses on three therapeutic areas with unmet medical need from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and Oncology. Through superior execution, Ascletis rapidly advances its pharmaceutical pipeline and strives to stay ahead of global competition. Ascletis has multiple drug candidates in its pipeline to date. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (relapsed glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).

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SOURCE Ascletis Pharmaceuticals, Inc.

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