China-based Ascletis Pharma Inc. (HKG: 1672) has announced its decision to terminate the Phase II clinical study for ASC42 in primary biliary cholangitis (PBC) following a comprehensive data analysis. The farnesoid X receptor (FXR) agonist will also see the cancellation of studies in non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV).
The Phase II trial for ASC42 in PBC involved three active treatment groups (5mg, 10mg, and 15mg once daily) alongside a placebo control group. Results from the 12-week efficacy and safety assessment indicated that ASC42 lacks a competitive edge compared to emerging PBC therapies currently in development and registration.
As of December 31, 2023, Ascletis reported cash and cash equivalents of approximately RMB 2.3 billion. The decision to discontinue ASC42 is part of a strategic initiative to optimize the company’s R&D pipeline and conserve cash. Funds saved from this decision will be redirected to advancing clinical studies for the thyroid hormone receptor β (THR) β agonist ASC41 and the fatty acid synthase (FASN) inhibitor ASC40 (denifanstat) in NASH and other indications.- Flcube.com
