Ascletis Pharma Inc. (HKG: 1672) announced that its wholly – owned US unit, Gannex, has initiated the first subject dosing in a drug – drug interaction (DDI) study for its drug candidate ASC42 in primary biliary cholangitis (PBC) in the United States. The study is designed to provide additional evidence to support upcoming Phase III clinical trials in China, the US, and the European Union, and is expected to be completed during Q4 of 2022.
Drug Details
ASC42 is an in – house developed, novel non – steroidal, selective, potent FXR agonist. It has completed Phase I clinical trials in China and the US, with Phase II studies currently underway in China. The previous Phase I clinical trial in the US (ClinicalTrials.gov Identifier: NCT04679129) demonstrated promising results, indicating that ASC42 could be a best – in – class PBC drug candidate. The trial showed that ASC42 produced LDL – C levels within the normal range without pruritus occurrence and increased the FXR target engagement biomarker FGF19 by 1,780% when dosed at 15 mg once daily (QD) over a 14 – day treatment period.
Future Plans
Gannex plans to initiate Phase III clinical trials in China, the US, and the EU upon completion of the current Phase II study in China.-Fineline Info & Tech
