A randomized, placebo-controlled study in mild to moderate COVID-19 patients has been approved by the US Food and Drug Administration (FDA).
The Investigational New Drug (IND) application for ASC10, an oral drug candidate targeting RNA-dependent RNA polymerase (RdRp) for COVID-19 was granted to China-based Ascletis Pharma Inc today (August 3), to conduct a Phase 1b clinical trial.
Ascletis will immediately initiate the clinical trial in patients to collect ASC10’s clinical safety, pharmacokinetics and preliminary efficacy data.
ASC10 is an orally bioavailable 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.
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.
The FDA recommended that Ascletis directly conduct the first clinical study of ASC10 in mild-to-moderate COVID-19 patients rather than in healthy subjects.
The study is a randomized, placebo controlled phase 1b clinical trial to determine the safety, tolerability, pharmacokinetics and preliminary efficacy in multiple ascending doses of ASC10 tablets (200 mg, 400 mg or 800 mg twice daily) in mild-to-moderate COVID-19 patients for 5.5-day treatment with 28-day monitoring.
Previously, molnupiravir was granted Emergency Use Authorization by the FDA for 800 mg twice daily.
Ascletis said it is actively communicating with regulatory authorities to explore the possibility of further accelerating the clinical development of ASC10.
Jinzi Wu, CEO at Ascletis, said: “The COVID-19 pandemic continues to cause huge social and economic implications globally with over 572 million cases been confirmed including more than 6 million deaths. As a leading biotech with in-depth insights into viral diseases, Ascletis is committed to leveraging its proprietary pipeline including ASC10 (RdRp inhibitor) and ASC11 (3CLpro inhibitor) to fight against the pandemic.
“This IND approval of ASC10 from FDA marks a great recognition to our in-house R&D capabilities and enables us to expedite the clinical progress of ASC10. With other efforts made on capacity expansion and process optimization, we have further improved the accessibility and affordability of ASC10.”
Ascletis is a research and development driven biotech listed on the Hong Kong Stock Exchange covering the entire value chain from discovery and development to manufacturing and commercialization.