Ascletis Pharma Inc. (HKG: 1672), a Chinese pharmaceutical company, has announced positive interim results from a 52-week Phase II study evaluating the efficacy of the thyroid hormone receptor β (THRβ) agonist ASC41 in patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH).
The ongoing, randomized, double-blind, placebo-controlled, and multi-center Phase II study in China is enrolling 180 patients, who are randomly assigned to two ASC41 treatment cohorts (2mg or 4mg once a day) and a placebo-controlled cohort in a 1:1:1 ratio. The study includes 52 weeks of treatment and a 4-week follow-up period. The pre-set interim analysis was conducted after 42 enrolled patients completed 12 weeks of ASC41 or placebo treatment. Compared to placebo, ASC41 demonstrated statistically significant and clinically meaningful reductions in liver enzymes ALT and AST, suggesting a distinct profile among THRβ agonists in clinical trials or at regulatory filing stages. Patients treated with ASC41 also showed a statistically and clinically significant decrease in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglycerides (TG) from baseline by 27.7%, 23.4%, and 46.5%, respectively.
ASC41 was found to be well tolerated, with the majority of adverse events (AEs) in each cohort, including the placebo cohort, being level 1. Among patients taking ASC41 tablets, only two patients (2/28, 7.1%) reported drug-related grade 2 treatment emergent adverse events (TEAEs), with no drug-related grade 3 or higher TEAEs observed. Only one patient (1/28, 3.6%) withdrew from the study due to drug-related grade 1 TEAEs.- Flcube.com
