China-based Ascletis Pharma Inc. (HKG: 1672) has announced positive results from a Phase I clinical study for its oral double prodrug ASC10. The findings were presented at the CROI 2023 annual meeting, marking a significant step forward in the development of this promising therapeutic candidate.
Phase I Clinical Data Highlights
The Phase I clinical data revealed that at a dosage of 800 mg ASC10 twice a day, the exposure of the active drug ASC10-A was found to be equivalent to that of molnupiravir. ASC10 demonstrated a favorable safety and tolerability profile. Within the tested dose range of 50 mg to 800 mg, ASC10-A plasma exposure increased proportionally with the dose. Notably, there was no accumulation and no significant impact from food after multi-dose administration.
Advancing to Further Clinical Trials
Encouraged by these results, Ascletis has decided to proceed with a Phase IIa clinical trial for respiratory syncytial virus (RSV) infection in the US, using a dosage of 800 mg twice a day. Additionally, the company plans to conduct a Phase III clinical study for COVID-19 in China.
ASC10’s Mechanism and Patent Protection
After oral administration, both ASC10 and the mono-prodrug molnupiravir are rapidly and completely converted into the same active drug ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931. Pre-clinical studies have indicated that ASC10-A possesses broad-spectrum antiviral activity, as well as strong antiviral effects against the novel coronavirus, monkeypox virus, and RSV. Ascletis has secured a patent for ASC10 and its derivatives, along with their uses in treating multiple virus infections, from the United States Patent and Trademark Office (USPTO). This includes coverage for SARS-CoV-2, monkeypox virus, and RSV.-Fineline Info & Tech
