Ascletis Announces IND Approval of Oral 3CLpro Inhibitor ASC11 for COVID-19 by China NMPA

Ascletis Pharma has announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19.

The objective of Phase I clinical trial is to identify a safe and efficacious dose for the pivotal Phase II/III in COVID-19 patients. Phase I clinical trial is expected to be completed within the first quarter of 2023. Furthermore, Phase I clinical trial will determine if ASC11 needs to be boosted by ritonavir or not. In antiviral cellular assays with infectious SARS-CoV-2, ASC11 demonstrated much higher potency against SARS-CoV-2 than other 3CLpro inhibitors including Nirmatrelvir, S-217622, PBI-0451 and EDP-235. 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.

“The IND approvals of ASC11 from both China NMPA and U.S. FDA mark a great recognition to our in-house R&D capabilities. We will continue to advance the clinical development of our proprietary COVID-19 pipeline including ASC10 (RdRp inhibitor) and ASC11 (3CLpro inhibitor),” said Founder, Chairman and CEO of Ascletis Dr. Jinzi J. Wu.