China-based Ascletis Pharma Inc. (HKG: 1672) has announced that the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been filed with the US FDA following a pre-IND consultation. This marks a significant step forward in the development of innovative treatments for COVID-19.
ASC11 Profile
ASC11 is an in-house discovered oral small molecule drug candidate utilizing various proprietary technologies, including molecular docking. Ascletis has filed global patent applications for ASC11 and related compounds for their use in viral diseases. In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated higher potency against SARS-CoV-2 compared to other 3CLpro inhibitors, including Nirmatrelvir, S-217622, PBI-0451, and EDP-235. ASC11 maintains potent antiviral activity against various popular Omicron variants, such as BA.1 and BA.5. In animal models with infectious SARS-CoV-2, ASC11 also showed potent antiviral activity.
Regulatory Progress
As of today, Ascletis has completed all IND-enabling studies for ASC11, including Good Laboratory Practice (GLP) toxicology studies in rats and dogs. The filing of the IND application with the FDA underscores Ascletis’ commitment to advancing innovative antiviral therapies and addressing the ongoing challenges posed by COVID-19.
Future Development
The IND application for ASC11 highlights Ascletis’ dedication to developing effective treatments for COVID-19. By leveraging its proprietary technologies and global patent portfolio, Ascletis aims to bring a new oral antiviral option to patients, potentially enhancing treatment outcomes and contributing to the global fight against the pandemic.-Fineline Info & Tech
