Ascletis Pharma Inc. announced that the Investigational New Drug (IND) application of ASC10, an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) for Coronavirus Disease 2019 (COVID-19), has been filed to the FDA after the Pre-IND consultation.
Targeting RdRp of SARS-CoV-2 virus, ASC10 is an oral small molecule drug candidate for patients with COVID-19. ASC10 is an orally bioavailable, double prodrug of the antiviral nucleoside analog ASC10-A, which demonstrates potent inhibitory effect of RdRp of SARS-CoV-2 virus. ASC10-A demonstrated an excellent in vitro antiviral activity against multiple SARS-CoV-2 virus variants including Omicron in preclinical studies.
Ascletis is committed to developing and manufacturing safe, effective, affordable oral drugs for COVID-19 globally. As a leading biotech company in China, Ascletis has completed IND filing of ASC10, an oral RdRp inhibitor drug candidate for COVID-19 with the U.S. FDA. At the same time, the IND filing of ASC10 in China is proceeding on track.
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