Hepion starts Phase 2b ‘ASCEND-NASH’ Trial

 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has screened the first subject in the ASCEND-NASH clinical trial. The trial is being conducted at up to 121 sites in seven countries, with 85 of the sites located within the U.S.

ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study to evaluate the safety and efficacy of rencofilstat in 336 subjects dosed for 12 months. Subjects included in the trial will be either F2 or F3 biopsy-confirmed, with enrollment of F3 subjects of at least 60%, to focus on NASH subjects with more advanced fibrosis. Subjects will receive either placebo or rencofilstat, administered orally once daily at doses of 75, 150, or 225 mg (n=84 subjects/cohort). Endpoints will evaluate improvements in both fibrosis and steatosis, with the overall study primary endpoint being an improvement of fibrosis score by one point without a worsening of steatosis, or an improvement of steatosis without worsening of fibrosis. Although the main trial endpoint is histologic and determined by changes in the biopsy, numerous other non-invasive markers (“NIM”) will be assessed, including NASH efficacy biomarkers, magnetic resonance elastography (“MRE”), and multiomics (e.g. proteomics and transcriptomics).

https://finance.yahoo.com/news/hepion-pharmaceuticals-announces-initiation-phase-120000431.html