China-based Ascletis Pharma Inc. (HKG: 1672) has provided updates on the clinical progress of ASC10, its oral RNA-dependent RNA polymerase (RdRp) drug therapy for COVID-19. The National Medical Products Administration (NMPA) has accepted an Investigational New Drug (IND) filing for review, and the US Food and Drug Administration (FDA) has approved another IND, enabling a Phase Ib clinical study.
Drug Details
ASC10 is an orally bioavailable double prodrug with a novel chemical structure distinct from molnupiravir. Both ASC10 and molnupiravir convert in vivo into the active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC). Ascletis has filed multiple global patent applications for ASC10 and its use.
Clinical Trials
The US FDA recommended conducting the first clinical study of ASC10 directly in mild-to-moderate COVID-19 patients. The Phase Ib trial is randomized and placebo-controlled, aiming to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of ASC10 tablets (200 mg, 400 mg, or 800 mg twice daily) over 5.5 days with 28-day monitoring. Previously, molnupiravir received Emergency Use Authorization (EUA) from the FDA for 800 mg twice daily.-Fineline Info & Tech
