Ascletis Pharma Inc. announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for Covid-19.
US FDA has approved to study safety, tolerability and pharmacokinetics of ASC11 at various doses in healthy subjects co-dosed with 100 mg ritonavir tablets. Both ASC11 and ritonavir tablets are manufactured by Ascletis.
The phase I clinical trial will consist of 3 cohorts in healthy subjects, including single- and multiple-dose escalation studies and food effect study. The objective of phase I trial is to find a right dose to move into the pivotal phase II/III in Covid-19 patients.
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.
"In addition to safety data, this Phase I trial will confirm whether ASC11 needs to be boosted with ritonavir or not,
