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

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

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

Shots:

  • 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

Ref: Ascletis | Image: Ascletis

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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