Ascletis Pharma has dosed 24 healthy subjects of the first three cohorts in a Phase I clinical trial of oral ASC10 tablets to treat Covid-19.
These subjects in the multiple-dose escalation trial of ASC10 were dosed at the National Medical Center for Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University.
The trial is set to recruit 72 healthy participants, with enrolment anticipated to conclude in the fourth quarter of this year.
In this trial, 60 subjects will be randomised into six cohorts and given escalated multiple doses of the oral double prodrug ASC10.
They will receive 50mg, 100mg, 200mg, 400mg, 600mg, and 800mg of the tablets two times a day, or a matching placebo for 5.5 days in a placebo-controlled, double-blind manner for assessing their tolerability, safety, and pharmacokinetics (PK).
Another 12 participants will be randomised and given two single 800mg doses for evaluating the food effect on ASC10 tablets’ PK.
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Ascletis founder, chairman and CEO Dr Jinzi Wu said: “ASC10-A has broad antiviral activity against Omicron variants including the most spread variant BA.5 and the emerging variant BA.2.75.
“A recent study published by The New England Journal of Medicine (NEJM) showed that ASC10-A, also known as EIDD-1931, remains effective against the most spread variant BA.5 and the emerging variant BA.2.75 which has been spread across at least 25 countries and designated by the World Health Organization as a ‘variant of concern lineage under monitoring’.
“We will continue to accelerate the clinical development of our proprietary Covid-19 pipeline including ASC10 (RdRp inhibitor) and ASC11 (3CLpro inhibitor) to fight against the pandemic.”
In August this year, Ascletis received the US Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for ASC10 to carry out the Phase Ib trial in mild-to-moderate Covid-19 patients.