Shanghai Junshi Biosciences has dosed the first subject in the Phase III clinical trial of an investigational drug, VV116, to treat moderate-to-severe Covid-19.
An oral nucleoside analog anti-SARS-CoV-2 drug, VV116 is designed to hinder virus replication.
It is co-developed by Junshi along with Vigonvita Life Sciences.
In preclinical studies, VV116 demonstrated substantial anti-SARS-CoV-2 effects in vivo and in vitro, had increased oral bioavailability and good chemical stability.
Furthermore, the drug demonstrated to possess antiviral activity against original viral strain and key variants including Alpha, Beta, Delta and Omicron.
The global, double-blind, multicentre, randomised, controlled trial will analyse the safety and efficacy of VV116 versus standard treatment in moderate to severe Covid-19 patients.
The percentage of subjects who advance to critical/severe Covid-19 or all-cause mortality within 29 days is the primary endpoint of the trial.
Apart from this Phase III trial, Junshi and Vigonvita commenced a global, double-blind, multicentre, randomised, placebo-controlled Phase II/III trial of VV116 in subjects with mild-to-moderate Covid-19.
This Phase II/III trial which has currently enrolled and dosed the first participant in China, will assess the safety, efficacy and pharmacokinetics of VV116 as an early treatment for mild to moderate disease.
It has a primary endpoint identical to the Phase III trial.
According to initial data from three concluded Phase I trials analysing the safety, tolerability and pharmacokinetics of VV116 in healthy Chinese participants, the drug demonstrated to have favourable clinical safety.
Findings from a Phase II trial of VV116 in Uzbekistan last year showed that two varying doses of the drug were found to have encouraging safety in moderate and severe Covid-19 patients versus standard treatment.
Based on these data, VV116 obtained approval in Uzbekistan last year to treat patients with moderate to severe Covid-19.
In June 2020, Junshi dosed the first healthy subject in the Phase I trial of JS016, its SARS-CoV-2 neutralising antibody.