China-based Ascletis Pharma Inc. (HKG: 1672) made a poster presentation detailing the abstract of a Phase I study for ASC43F in a single dose to treat non-alcoholic steatohepatitis (NASH) at The Liver Meeting 2022 of the American Association for the Study of Liver Diseases (AASLD). The presentation highlighted the drug’s safety, tolerability, and pharmacokinetic profile in healthy subjects.
Study Design and Objectives
The ASC43F-101 open-label, single-dose Phase I study is designed to assess the safety, tolerability, and pharmacokinetics of ASC43F, a compound preparation composed of a thyroid hormone receptor beta agonist and ASC42, a farnesoid X receptor agonist. The study is expected to enroll 8 healthy subjects aged 18-65 years old.
Clinical Trial Results
The Phase I study demonstrated that ASC43F showed good tolerability and safety profiles. The pharmacokinetic (PK) parameters of ASC41/ASC41A and ASC42 from ASC43F were similar to those of ASC41 and ASC42 as monotherapy. These findings suggest that the combination therapy has the potential to be an effective treatment for NASH, a condition characterized by liver inflammation and fat accumulation not related to alcohol use.
Future Development
The positive results from the Phase I study support the continued development of ASC43F for the treatment of NASH. Ascletis Pharma is committed to advancing this innovative therapy to address the significant unmet medical need in patients with this chronic liver disease.-Fineline Info & Tech
