Ascletis Announces U.S. IND Filing of Oral 3CLpro Inhibitor ASC11 for COVID-19

Ascletis Pharma Inc. announces that the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been filed to the U.S. Food and Drug Administration (FDA) after the Pre-IND consultation.

In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated higher potency against SARS-CoV-2 than other 3CLpro inhibitors including Nirmatrelvir, S-217622, PBI-0451 and EDP-235, etc. ASC11 remains potent antiviral activity against various popular Omicron variants such as BA.1 and BA.5. In the animal model with infectious SARS-CoV-2, ASC11 also showed potent antiviral activity.

ASC11 is an in-house discovered oral small molecule drug candidate using various proprietary technologies including molecular docking. Ascletis has filed global patent applications for ASC11 and related compounds and their use in viral disease.

Ascletis has completed all IND enabling studies for ASC11 including Good Laboratory Practice (GLP) toxicology studies in rats and dogs as of today.