Ascletis’ ASC11 Receives the US FDA’s IND Approval for the Treatment COVID-19


The US FDA has approved the IND application to initiate the P-I trial that consists of 3 cohorts incl. single & multiple-dose escalation studies and food effect studies evaluating the safety, tolerability & PK of ASC11 (100mg) in healthy patients. ASC11 & ritonavir are manufactured by Ascletis
The trial focuses to determine the right dose to move into the P-II/III trial in COVID-19 patients. In antiviral cellular assays with infectious SARS-CoV-2, ASC11 showed a higher potency against SARS-CoV-2 over other 3-chymotrypsin-like proteases (3CLpro) inhibitors incl. Nirmatrelvir, S-217622, PBI-0451 & EDP-235
Ascletis has submitted global patent applications for the use of ASC11 (oral inhibitor drug candidate targeting 3CLpro) & related compounds in viral disease

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