Policy & Regulation
Ascletis Pharma's IND application for COVID-19 drug ASC11 receives US FDA approval
24 November 2022 -

Ascletis Pharma Inc. (HKEX: 1672), a China-based innovative R&D driven biotech company, announced on Wednesday that the United States Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate aimed at 3-chymotrypsin like protease (3CLpro) for COVID-19.

The company has received approval to study the safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects co-dosed with 100mg ritonavir tablets. The company has produced both ASC11 and ritonavir tablets.

The Phase I clinical trial is to include three cohorts of healthy patients, including single- and multiple-dose escalation studies and a food impact study. The aim of the Phase one trial is to find the right dose to move into the pivotal Phase II/III in COVID-19 patients.