The China National Medical Products Administration (NMPA) has granted approval for Ascletis Pharma’s Investigational New Drug (IND) application for the Phase I clinical trial of its drug candidate, ASC11, for Covid-19.
The trial aims to identify a safe and efficacious dose of ASC11 for the pivotal Phase II/III trial in patients with Covid-19.
Anticipated to conclude within the first quarter of next year, the Phase I trial will analyse if ASC11 requires boosting with ritonavir or not.
The drug candidate showed increased potency against the SARS-CoV-2 virus, compared with 3-chymotrypsin like protease (3CLpro) inhibitors including S-217622, Nirmatrelvir, PBI-0451 and EDP-235, in antiviral cellular assays with infectious virus.
In addition, ASC11 was found to have potent antiviral activity against BA.1 and BA.5 Omicron variants.
The drug also demonstrated antiviral activity in the infectious SARS-CoV-2 animal model.
Discovered in-house, ASC11 is an oral small molecule 3CLpro inhibitor.
Ascletis founder, chairman and CEO Dr Jinzi Wu said: “The IND approvals of ASC11 from both China NMPA and US FDA mark a great recognition to our in-house R&D capabilities.
“We will continue to advance the clinical development of our proprietary Covid-19 pipeline including ASC10 (RdRp inhibitor) and ASC11 (3CLpro inhibitor).”
In October this year, the company dosed 24 healthy participants in the first three cohorts in a Phase I trial of oral ASC10 tablets for Covid-19.
The multiple-dose escalation trial is expected to enrol 72 subjects, with enrolment planned to conclude in the fourth quarter of this year.