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Ascletis Announces U.S. FDA Approval for Conducting a Phase IIa Clinical Trial

Wednesday, February 01, 2023

Ascletis Pharma announced that the U.S. Food and Drug Administration (“FDA”) has approved to conduct a Phase IIa clinical trial for ASC10 to treat respiratory syncytial virus (RSV) infection. Based on available data, dosage of 800 mg ASC10, twice daily was selected to conduct a randomised, double-blind, placebo-controlled Phase IIa study to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of ASC10 tablets in patients with mild or moderate RSV infection.

Dosage of 800 mg ASC10, twice daily is selected to conduct a Phase IIa study in patients with RSV infection.

ASC10 is an oral dual prodrug. After oral administration, ASC10 is rapidly and completely converted in vivo to the active metabolite ASC10-A, also known as β-D-N -hydroxycytidine (NHC) or EIDD-1931. Preclinical studies have shown that ASC10-A (NHC) is a potent inhibitor with an EC50 of 0.51-0.6 µM against two clinical RSV isolates using an in vitro infection assay in HEp-2 cells. In addition, preclinical studies have shown that ASC10-A (NHC) is effective in a mouse model of RSV infection.

Respiratory syncytial virus (RSV) infection treatment is the huge unmet medical needs and there are no approved drugs so far for the treatment globally. ASC10 U.S. FDA approval to conduct a Phase IIa study to treat RSV infection in patients, represents a new milestone of Ascletis' R&D in treatment for viral diseases.

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