Ascletis Pharma has received the US Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for the oral drug candidate, ASC10, to carry out the Phase Ib trial in mild-to-moderate Covid-19 patients.
With this development, the company will quickly commence the trial in these patients to obtain the clinical safety, pharmacokinetics and initial efficacy data of ASC10.
According to the recommendation from the regulatory agency, Ascletis was asked to directly carry out the trial of ASC10 in patients with mild-to-moderate Covid-19 instead of healthy participants.
The placebo-controlled, randomised trial will analyse the safety, tolerability, pharmacokinetics and initial efficacy in various ascending doses of ASC10 tablets (200mg, 400mg or 800mg).
Trial subjects will receive the oral drug twice a day as a part of the 5.5-day treatment and monitored for 28 days.
The company is presently in talks with the regulatory agencies to analyse the potential to further expedite ASC10’s clinical development.
An orally bioavailable double prodrug, ASC10 acts on RNA-dependent RNA polymerase (RdRp).
In vivo, the drug is quickly converted into active metabolite ASC10-A, which is also an active metabolite for molnupiravir, an FDA-authorised therapy.
In the SARS-CoV-2 infected mouse models, 240mg/kg twice a day dose of ASC10 offered a 4.0 log decline in viral titer in the lungs, which was in line with 500 mg/kg twice daily dose of molnupiravir
Ascletis founder, chairman and CEO Dr Jinzi Wu said: “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 optimisation, we have further improved the accessibility and affordability of ASC10.”
Meanwhile, the China National Medical Products Administration (NMPA) also accepted the company’s IND application for ASC10.