On April 3, Gelonghui Pharmaceutical-B (01672.HK) announced a strategic decision on the farnesol X receptor (FXR) agonist ASC42. After thorough analysis of the ASC42 phase II clinical trial (ClinicAlt rials.gov: NCT05190523) data for primary biliary cholangitis (PBC), the company made a strategic decision not to continue clinical trials with ASC42 for PBC. The decision was based on efficacy and safety data from the 12-week phase II study, which included three ASC42 active treatment groups (5 mg, 10 mg, and 15 mg, once daily) and a placebo control group. The results showed that ASC42 showed no competitive advantage compared to novel PBC drug candidates currently in the development and registration stages.
In addition, the company also decided not to continue clinical research on the FXR agonist ASC42 in combination with the treatment of non-alcoholic steatohepatitis (NASH) (ASC43F), as well as clinical studies of ASC42 in the treatment of hepatitis B.
As of December 31, 2023, the company's cash and cash equivalents and time deposits were approximately RMB 2.3 billion. These strategic decisions are part of the company's efforts to continue to evaluate and optimize R&D pipelines to improve efficiency and conserve cash. The funds saved from the original planned trial will be used to accelerate clinical research on ASC41 and ASC40 for NASH indications and the development of the world's first or best-in-class drug candidate. The phase II clinical trial of ASC41 in NASH patients confirmed by liver biopsy yielded positive interim results, indicating that ASC41 is expected to be the best thyroid hormone receptor beta (THRβ) agonist in its class. As the first FASN inhibitor of its kind, a 52-week phase IIb clinical trial of ASC40 (denifastat) in treating patients with stage 2 or stage 3 NASH fibrosis confirmed by liver biopsy showed that ASC40 achieved statistically significant results in both NASH relief and fibrosis improvement.