Biotechnology company Ascletis Pharma Inc (HKEX: 1672) reported on Wednesday that its Investigational New Drug (IND) application for ASC11 has been approved by China National Medical Products Administration (NMPA).

ASC11 is an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19.

The company said that the objective of the Phase I clinical trial is to identify a safe and efficacious dose for the pivotal Phase II/III in COVID-19 patients. The Phase I clinical trial is expected to be completed within the first quarter of 2023 and will determine if ASC11 needs to be boosted by ritonavir or not.

According to Ascletis, ASC11 demonstrated much higher potency against SARS-CoV-2 in antiviral cellular assays with infectious SARS-CoV-2, compared to 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.