The results of a Phase III clinical study for China-based Junshi Biosciences’ (HKG: 1877, SHA: 688180) oral nucleoside analog drug JT001 (VV116) have been published in the New England Journal of Medicine. The study compared VV116 with Pfizer’s Paxlovid (nirmatrelvir + ritonavir) as an early treatment for mild to moderate COVID-19 infection in patients with severe progression, including high-risk factors for death. This non-inferiority, blinded, randomized Phase III trial is the first head-to-head Phase III study for a small molecule COVID-19 drug in Chinese patients during the outbreak caused by the B.1.1.529 (omicron) variant of SARS-CoV-2.
Study Design and Results
A total of 822 participants underwent randomization, with 771 receiving VV116 (384 participants) or nirmatrelvir-ritonavir (387 participants). Secondary efficacy endpoints included progression to severe or critical Covid-19 or death from any cause; changes in Covid-19-related symptom score and the score on the WHO Clinical Progression Scale through day 28; time to sustained resolution of all target symptoms and to a first negative SARS-CoV-2 test; and clinical recovery, symptom resolution, and a negative SARS-CoV-2 test by prespecified days. Safety endpoints included adverse events and serious adverse events. No participants in either group died or had progression to severe Covid-19 by day 28. The incidence of adverse events was lower in the VV116 group than in the nirmatrelvir-ritonavir group (67.4% vs. 77.3%).
Drug Profile and Development
VV116 is a deuterated remdesivir hydrobromide with oral bioavailability and potent activity against SARS-CoV-2 in studies in animals. It has demonstrated satisfactory safety and side-effect profiles in Phase I trials. The drug is currently undergoing a global, multi-center Phase III clinical study and multiple regulatory studies in mild to moderate and moderate to severe COVID-19 cases. VV116 has been approved to treat moderate to severe COVID-19 in Uzbekistan.-Fineline Info & Tech
