Junshi Biosciences Submits Prospectus for Phase III Head-to-Head Trial of Oral Antiviral VV116 (JT001) Versus Pfizer’s Paxlovid in Mild-to-Moderate COVID-19

On April 19, the China Clinical Trial Registry showed that Suzhou Vigonvita Life Sciences Co., Ltd. registered a multi-center, single-blind, randomized, controlled Phase III clinical study evaluating the efficacy and safety of JT001 (VV116) compared to Pfizer's Paxlovid in the early treatment of mild to moderate Coronavirus Disease 2019 (COVID-19).

VV116 is a novel oral nucleoside analog anti-SARS-CoV-2 drug jointly developed by multiple institutions, including the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, the Wuhan Institute of Virology of the Chinese Academy of Sciences, and Suzhou Vigonvita Life Sciences Co., Ltd. It inhibits viral RNA synthesis by targeting the RNA-dependent RNA polymerase (RdRp).

In September 2021, Junshi Biosciences and Vigonvita reached a cooperation agreement to jointly undertake the clinical development and industrialization of VV116 worldwide. On December 30, 2021, VV116 received emergency use authorization in Uzbekistan. Studies have shown that VV116 exhibits antiviral activity against Alpha, Beta, Delta, and Omicron, while also demonstrating high oral bioavailability and good chemical stability.

Paxlovid, an oral COVID-19 medication developed by Pfizer, received conditional import approval from the National Medical Products Administration on February 11 this year. It is used to treat adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19) who are at high risk of progressing to severe disease, such as those with advanced age, chronic kidney disease, diabetes, cardiovascular disease, chronic lung disease, and other high-risk factors for severe illness.

Paxlovid is a combination drug consisting of the 3CL protease inhibitor nirmatrelvir and a low dose of ritonavir (Ritonavir). It is administered orally to COVID-19 patients as a combination of 300mg (two 150mg tablets) of nirmatrelvir and one 100mg tablet of ritonavir, given twice daily for five days.

The dosing regimens of the two drugs are as follows: Treatment group: JT001 (VV116) 600mg Q12H × 1 day, 300mg Q12H × 4 days; Control group: Paxlovid, Nirmatrelvir Tablets 300mg + Ritonavir Tablets 100mg, Q12H × 5 days.

A total of 480 participants were enrolled, with 240 in the treatment group and 240 in the control group. The study was conducted at Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine.

The primary endpoints were the time to sustained clinical recovery (up to Day 28) and the percentage of participants with COVID-19 progression (defined as progression to severe/critical COVID-19 or all-cause mortality) up to Day 28.