Shanghai Junshi Biosciences has reported that the Phase III clinical trial of VV116 (JT001) and Pfizer‘s Paxlovid (nirmatrelvir/ritonavir) to treat Covid-19 patients has reached its primary endpoint.
The study is comparing the efficacy and safety of the oral nucleoside analogue drug and Paxlovid in patients who have mild-to-moderate Covid-19 and are at increased risk for disease progression.
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The Phase III trial (NCT05341609) reached the pre-specified primary and secondary efficacy endpoints.
It was found that VV116 provided patients with a reduced median time to sustained clinical recovery.
The multicentre, randomised, single-blind, controlled trial, involving a total of 822 patients, was conducted following communication with regulatory authorities.
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A single-blind design was adopted to hide the therapeutic drug distribution to both the investigators, including the endpoint evaluator and the study sponsor.
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By GlobalDataTime to sustained clinical recovery was the primary endpoint of the study.
Percentage of participants with disease progression by day 28, time to sustained clinical symptoms disappearance, and percentage of subjects who turned negative for SARS-CoV-2, were included as some of the secondary endpoints.
In the trial, subjects in the VV116 arm showed a shorter time to sustained clinical recovery compared to those in the Paxlovid arm.
No Covid-19 disease progression or death was observed in the VV116 arm or Paxlovid arm in terms of the secondary efficacy endpoints.
Furthermore, the research team observed that the drug has a good safety profile, and its overall incidence of adverse events is lower compared to Paxlovid.
Junshi Biosciences developed the new oral nucleoside analogue anti-SARS-CoV-2 investigational drug along with Vigonvita Life Sciences.
In March this year, Junshi Biosciences dosed the first subject in the Phase III study of VV116 to treat moderate-to-severe Covid-19.
