China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to conduct a Phase IIa clinical study for its investigational drug ASC10 in patients with respiratory syncytial virus (RSV) infection. ASC10 is an oral double prodrug designed to be rapidly and completely converted in vivo into its active metabolite, ASC10-A (β-D-N4-hydroxycytidine, or NHC).
ASC10 Mechanism and Preclinical Data
Preclinical research has shown that ASC10-A is a potent inhibitor of RSV, with an EC50 of 0.51 to 0.6 µM against two RSV clinical isolates using an in vitro infection assay in HEp-2 cells. Additionally, studies in a mouse model of RSV infection demonstrated the efficacy of ASC10-A, positioning it as a promising candidate for treating RSV infections.
Intellectual Property and Broad Antiviral Potential
Ascletis has secured a patent for ASC10 and its derivatives from the United States Patent and Trademark Office (USPTO). The patent covers the use of ASC10 for treating multiple viral infections, including SARS-CoV-2, monkeypox virus, and RSV. This broad-spectrum antiviral potential underscores Ascletis’ commitment to developing innovative therapies for significant unmet medical needs.-Fineline Info & Tech
