By Fineline Cube China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the green light to conduct a Phase IIa study for its ASC10 in the treatment of respiratory syncytial virus (RSV) infection. This follows the company’s previous approval from the US FDA in January 2023 to carry out a similar Phase IIa study for ASC10 as an RSV infection treatment.
ASC10: An Oral Double Prodrug with Potent Inhibitory Effects
ASC10 is an oral double prodrug that rapidly and completely converts in vivo into the active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931, after oral administration. Preclinical research has shown that ASC10-A (NHC) is a potent inhibitor with an EC50 of 0.51 to 0.6 uM against two RSV clinical isolates in an in vitro infection assay using HEp-2 cells. Moreover, preclinical studies have demonstrated the efficacy of ASC10-A (NHC) in a mouse RSV infection model. Ascletis has been granted a patent by the United States Patent and Trademark Office (USPTO) for ASC10 and its derivatives, covering their use against multiple viral infections, including SARS-CoV-2, monkeypox virus, and RSV.
Significance of RSV Treatment and Market Potential
Globally, RSV affects an estimated 64 million people and causes 160,000 deaths each year, representing a significant unmet medical need. There are currently no effective treatment options available. According to a report from Astute Analytica, the global market for RSV therapies is projected to grow at a compound annual growth rate (CAGR) of 14.9% from 2022-2027, reaching a value of USD 4.2 billion by 2027.-Fineline Info & Tech