China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its ASC10, an oral double prodrug antiviral, to evaluate its potential as a treatment for monkeypox. This approval marks a significant step in expanding the therapeutic applications of ASC10.
ASC10 Mechanism and Development
ASC10 is an oral double prodrug that, like molnupiravir, is converted in vivo into the active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931. Preclinical studies conducted at the University of Illinois in the US have demonstrated that ASC10-A has broad-spectrum antiviral activities against both monkeypox and SARS-CoV-2 viruses.
Intellectual Property and Global Recognition
In January of this year, the US Patent and Trademark Office (USPTO) approved a patent application for ASC10 and its derivatives, covering their use against SARS-CoV-2, monkeypox virus, and respiratory syncytial virus (RSV). Ascletis is the first Chinese biotech company to receive a USPTO-granted patent for an in-house developed oral viral polymerase inhibitor.
Clinical Validation and Future Outlook
In August 2022, researchers from the National Institute of Infectious Diseases in Tokyo, Japan, tested 132 drugs, with results showing that molnupiravir (active metabolite ASC10-A) and two other drugs exhibited potent antiviral activity in monkeypox virus assays. This validation underscores the potential of ASC10 as a next-generation antiviral therapy, positioning Ascletis to address significant unmet needs in infectious diseases.-Fineline Info & Tech
