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Ascletis Pharma : FDA Approves IND Of Oral 3CLpro Inhibitor ASC11 For COVID-19

Ascletis Pharma Inc. said Wednesday that the U.S. Food and Drug Administration has approved the Investigational New Drug (IND) application of ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19.

The 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.

According to the company, 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 3-chymotrypsin like protease (3CLpro) inhibitors including Nirmatrelvir, S-217622, PBI-0451 and EDP-235.

Ascletis noted that it has filed global patent applications for ASC11 and related compounds and their use in viral disease.

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