An investigational new drug (IND) application for a COVID-19 treatment has been approved by the China National Medical Products Administration (NMPA).
The application is for ASC10, an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) that targets the COVID-19 virus.
Ascletis is China’s first biotech company to obtain IND approvals of an oral RdRp inhibitor from both the NMPA and the U.S. Food and Drug Administration (FDA).
ASC10 is an oral double prodrug, which has a new and differentiated chemical structure from the single prodrug molnupiravir. After oral administration, both ASC10 and molnupiravir are rapidly and completely converted in vivo into the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC).
ASC10 was discovered and developed in-house. Ascletis has filed multiple patent applications for ASC10 and its use globally. ASC10 oral tablet formulation for the clinical study was developed with in-house proprietary technology of Ascletis.
Ascletis said it is communicating with regulatory authorities to explore the possibility of further accelerating the clinical development of ASC10.
Jinzi Wu, founder and CEO of Ascletis, said: “The IND approvals of ASC10 from both China NMPA and U.S. FDA mark a great recognition to our in-house R&D capabilities. As the COVID-19 pandemic continues to cause huge social and economic implications globally, we will continue to advance the clinical development of our proprietary COVID-19 pipeline including ASC10, the RdRp inhibitor and ASC11 the 3CLpro inhibitor to fight against the pandemic.”