Junsil Biologics has opened new VV116 and Pfizer Paxlovid head-to-head phase III clinical trials

Junshi Biotech has announced the launch of a multicenter, double-blind, randomized, placebo-controlled Phase III trial to evaluate the efficacy and safety of JT001 (VV116) in subjects with mild to moderate novel coronavirus pneumonia (COVID-19) (Protocol No. : JT001-015-III-COVID-19) is being carried out.

JT001 (VV116) tablets are intended to be used in the treatment of novel coronavirus pneumonia (COVID-19). After being metabolized in the body, JT001 (VV116) tablets further form the active form of nucleoside triphosphate in cells, inhibit the RNA polymerase dependent on the novel coronavirus RNA, and thus play an antiviral role. The in vitro activity study of JT001(VV116) has proved that it has significant inhibitory effect on both the original virus strains and the main variants (beta, delta, omicron, etc.) of the novel coronavirus. This study has been approved by the National Medical Products Administration (approval number: CXHL2101625) and the Ethics Committee of the hospital. It is planned to enroll 1200 subjects nationwide.

According to the Chinese Clinical Trial Registry, on December 19, 2022, Junshitbio has registered a new Phase III clinical trial of VV116 head to head comparison of the rebound rate of Paxlovid in the treatment of mild to moderate COVID-19. The Phase III clinical study was conducted by Academician Ning Guang, President of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. 478 subjects were planned to be enrolled.

Objective: To compare the incidence of viral rebound in patients with mild to moderate novel coronavirus pneumonia (COVID-19) treated with VV116 or Nematavir tablet/Ritonavir tablet.

The primary measure was the rebound rate within 60 days of randomization (as determined by viral load in qRT-PCR).

Secondary indicators included viral rebound rate within 60 days after randomization (determined by Ct value of RT-PCR), viral rebound time after completion of treatment, COVID-19 rebound rate at 7, 14, 21, and 30 days after completion of treatment, and incidence of symptom exacerbation during follow-up after completion of treatment within 60 days after randomization compared to the assessment on the next day after completion of treatment, Incidence of persistent exacerbation of symptoms during follow-up after completion of treatment within 60 days of randomization compared to assessment on the next day after completion of treatment.