Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH).
Phase II Clinical Trial Design
The randomized, double-blind, placebo-controlled, and multi-center Phase II clinical trial aims to evaluate the safety and efficacy of ASC41 in treating liver biopsy-proven NASH patients. The trial will enroll approximately 180 patients, who will be randomized into two treatment arms and one placebo control arm at a 1:1:1 ratio. Participants will receive oral administration of ASC41 (2 mg or 4 mg) or placebo once daily for 52 weeks. Enrollment is expected to be completed in the third quarter of 2023.
Mechanism of ASC41
ASC41 is a liver-targeted prodrug whose active metabolite is a selective THRβ agonist. THRβ is highly expressed in the liver, and its agonists have been shown to reduce low-density lipoprotein (LDL), triglyceride (TG), and hepatic steatosis in humans. By promoting fatty acid breakdown and stimulating mitochondrial biogenesis, THRβ helps reduce lipotoxicity and improve liver function, thereby reducing liver fat.
Previous Clinical Trials
ASC41 previously concluded a randomized, double-blind, placebo-controlled single- and multiple-ascending dose Phase I clinical trial in January 2021. The oral tablets completed the US Phase I trial of drug-drug interactions in healthy subjects and pharmacokinetics (PK) in patients with non-alcoholic fatty liver disease (NAFLD) in September.-Fineline Info & Tech
