Ascletis Announces U.S. IND Filing of Oral RdRp Inhibitor Drug Candidate ASC10 for COVID-19
— ASC10 is an oral small molecule drug candidate, which is in-house discovered and developed, and Ascletis retains full global rights for its development and commercialization
–This IND filing of ASC10 in the U.S. will accelerate Ascletis’ global multi-center clinical studies on ASC10 and better position its oral drug pipeline of COVID-19
HANGZHOU, China and SHAOXING, China, July 6, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces 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 U.S. Food and Drug Administration (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.
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC10 and ASC11 (oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne).
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