Positive Mid-Study Outcomes for ASC41 Tablet in NASH Patients

In a recent Phase II clinical trial, the ASC41 tablet has shown promising results in reducing liver fat content in patients with non-alcoholic steatohepatitis (NASH). After a 12-week treatment period, the drug achieved a mean relative reduction in liver fat content of up to 68.2%. Impressively, 93.3% of the patients treated with the ASC41 tablet experienced at least a 30% relative reduction from their baseline liver fat content, a significant indicator of potential NASH resolution and fibrosis improvement.

The trial also reported a marked decrease in liver inflammatory biomarkers alanine aminotransferase (ALT) and aspartate aminotransferase (AST), with placebo-adjusted mean relative reductions reaching up to 37.8% and 41.5%, respectively. This suggests that the ASC41 tablet could be effective in addressing liver inflammation associated with NASH.

Furthermore, the study participants displayed substantial reductions in lipid levels, including low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglyceride (TG), with decreases of up to 27.7%, 23.4%, and 46.5% from baseline, respectively. These reductions could lead to an improved cardiometabolic profile and potentially lower the risk of cardiovascular events.

Safety and tolerability were also assessed, revealing that the ASC41 tablet was well-tolerated by patients. The majority of adverse events were grade 1, and gastrointestinal-related adverse events were comparable between the treatment and placebo groups. Importantly, there were no reports of drug-related grade 3 or higher treatment emergent adverse events, and only one patient discontinued the study due to a drug-related adverse event.

The ASC41 tablet, developed by Gannex Pharma Co., Ltd., a subsidiary of Ascletis Pharma Inc., is a liver-targeting and highly selective thyroid hormone receptor β (THRβ) agonist. The formulation of the once-daily tablet has been patented in the U.S., and the ongoing trial is expected to enroll approximately 180 NASH patients for a 52-week treatment period with a subsequent 4-week follow-up.

Dr. Jinzi J. Wu, CEO of Ascletis, expressed enthusiasm for the interim results, highlighting the tablet's potential as a leading THRβ agonist in treating NASH. The company anticipates further histological assessments via liver biopsy at the 52-week mark, which will provide additional insights into the drug's efficacy.

Ascletis, a biopharmaceutical company listed on the Hong Kong Stock Exchange, is committed to addressing unmet medical needs in viral diseases, NASH, and oncology. The company's robust R&D pipeline includes several drug candidates, with ASC41 being one of the frontrunners in the NASH therapeutic space.