The investigational antiviral showed the potential of another therapy that could benefit this patient population that is at risk for hospitalization and death.
VV116, an oral nucleoside antiviral drug, was shown to be noninferior to nirmatrelvir/ritonavir (Paxlovid) in a phase 3 trial comparing the efficacy and safety of the two therapies in the treatment of symptomatic patients with mild to moderate COVID-19 who were at high risk for progression to severe COVID-19 including death.
The results of the study were published recently in the New England Journal of Medicine.
“This noninferiority in efficacy was seen in the full analysis population, the per-protocol population, and in participants who started treatment within 5 days after symptom onset. The point estimates of secondary end points also suggested that VV116 was better than or similar to nirmatrelvir–ritonavir with respect to the time to sustained symptom resolution and to a first negative SARS-CoV-2 test,” the investigators wrote.
“Our study not only provided valuable information and experience for the development and clinical application of two major anti-SARS-CoV-2 small molecule drug routes, the RdRp inhibitor and the 3CL protease inhibitor, but also showed that our self-developed anti-SARS-CoV-2 oral drugs in China have similar efficacy and safety to Paxlovid,” coauthor and professor Ren Zhao of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, said in a statement.
The study, led by Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, is the first “head-to-head” phase 3 clinical study of small molecule oral anti-SARS-CoV drug in Chinese COVID-19 patients during the Omicron outbreak. The results indicated that the primary endpoint of the study realized the designed noninferiority endpoint, and VV116 group had a shorter time to sustained clinical recovery with less safety concerns as compared with nirmatrelvir–ritonavir.
This study was conducted in Shanghai, China in March to June 2022 during the Omicron outbreak.
In terms of safety, VV116, demonstrated limited issues. “Fewer adverse events occurred in the VV116 group than in the nirmatrelvir–ritonavir group. Unlike nirmatrelvir–ritonavir, which has drug–drug interactions with multiple medications, VV116 does not inhibit or induce major drug-metabolizing enzymes or inhibit major drug transporters, so interaction with concomitant medications is less likely,” the investigators wrote.
VV116 was independently developed in China that inhibits the replication of SARS-CoV-2. Preclinical studies haves hown that VV116 had significant antiviral effects in both original strain and known mutant strains, and exhibited satisfactory safety, tolerability, and pharmacokinetic properties in phase1 clinical studies. A preliminary small-scale study confirmed that patients, who were treated with VV116 within 5 days since they were tested positive after the first SARS-CoV-2 detection, had a shorter time to nucleic acid reversion compared to conventional therapy.
China has seen a drastic uptick in incidence rates, so treatments are warranted. “We hope that our study results can assist in our nation’s efforts to combat the epidemic,” Zhao said.
“We are continuing to invest in the clinical development of VV116 for use in other populations, with the goal of providing better and safer treatment options for COVID-19 patients in China and around the world with this exciting new therapy,” Jianjun Zou, Global Research and Development president at Junshi Biosciences, said in a statement.