China-based Ascletis Pharma Inc. (HKG: 1672) announced the poster presentation of ASC42, a novel farnesoid X receptor (FXR) agonist, at the European Association for the Study of the Liver (EASL) CONGRESS 2023. The study evaluated ASC42 in combination with PEGylated interferon (PEG-IFN) and entecavir (ETV) for the treatment of chronic hepatitis B (CHB) patients over a 12-week period.
Phase II Trial Design and Safety Profile
The Phase II trial (NCT05107778) was a multi-center, randomized, single-blind, placebo-controlled study conducted in China, focusing on HBeAg negative, hepatitis B virus (HBV) DNA patients. A total of 122, 119, and 107 adverse events (AEs) were reported in the 10 mg ASC42, 15 mg ASC42, and placebo (PBO) cohorts, respectively. The majority of AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. Notably, one subject in the 15 mg ASC42 cohort experienced a grade 3 serious AE (SAE) of liver function injury, which resulted in recovery. Pruritus was the most commonly reported AE, with study drug-related pruritus occurring in 1 (6.7%), 7 (50%), and 0 (0%) subjects in the 10 mg ASC42, 15 mg ASC42, and PBO cohorts, respectively. The pruritus rate of 10 mg ASC42 (6.7%) is lower than that observed with other FXR agonists in non-alcoholic steatohepatitis (NASH) patients.
Implications of ASC42 Trial Results
The safety profile of ASC42, as demonstrated in this Phase II trial, is an important consideration for its potential use in combination therapy for chronic hepatitis B patients. The lower rate of pruritus observed with ASC42, particularly in the 10 mg cohort, compared to other FXR agonists, may offer a more tolerable treatment option for patients.-Fineline Info & Tech
