echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Infection > Chaired by Academician Ning Guang, Junshi's new crown oral drug VV116 and Pfizer's Paxlovid conduct a head-to-head phase III trial

    Chaired by Academician Ning Guang, Junshi's new crown oral drug VV116 and Pfizer's Paxlovid conduct a head-to-head phase III trial

    • Last Update: 2022-06-10
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    On April 19, according to the China Clinical Trial Registration Center, Suzhou Wangshan Wangshui Biopharmaceutical registered an evaluation of JT001 (VV116) compared with Pfizer's Paxlovid in the early treatment of mild to moderate novel coronavirus pneumonia (COVID-19) effectiveness and A multicenter, single-blind, randomized, controlled III clinical study of safety
    .

      The head-to-head test is aimed at the early treatment of mild and moderate COVID-19.
    VV116 is a new oral nucleoside antibody jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Wuhan Institute of Virology, Chinese Academy of Sciences, Wangshan Wangshui Biomedical Co.
    , Ltd.
    and other institutions.
    SARS-CoV-2 drugs inhibit viral RNA synthesis by targeting RNA-dependent RNA polymerase (RdRp)
    .

    Preclinical pharmacodynamic studies have shown that VV116 exhibits significant antiviral effects on both the original and known mutant strains of 2019-nCoV in vitro
    .

    In September 2021, Junshi Biotech and Wangshan Wangshui reached a cooperation agreement to jointly undertake the clinical development and industrialization of VV116 worldwide
    .

    On December 30, 2021, VV116 received an emergency use authorization in Uzbekistan
    .

    Paxlovid is the world's first oral 3CL protease inhibitor developed by Pfizer against the new coronavirus.
    It was approved by the Food and Drug Administration for conditional import on February 11 this year.
    It is used for the treatment of adults with mild to moderate disease with high risk factors for progression to severe disease.
    Novel coronavirus pneumonia (COVID-19) patients, and has been included in the "New coronavirus pneumonia diagnosis and treatment plan (trial version 9)"
    .

    This clinical study will enroll 480 patients, using VV116 and 240 Paxlovid each, and the Phase 3 clinical trial will be from April 1, 2022 to December 31, 2022
    .

    The enrolled people are confirmed patients with new crowns with underlying diseases and a symptom score ≥ 2 points.
    The test site is Shanghai Ruijin Hospital.
    The research leader is the president of Ruijin Hospital and Shi Ningguang, an academician of the Chinese Academy of Engineering.

    .

    The dosage regimen was as follows: treatment group: JT001 (VV116) 600mg Q12H × 1 day, 300mg Q12H × 4 days; control group: Paxlovid, Nematevir tablets 300mg + Ritonavir tablets 100mg, Q12H × 5 days
    .

    There are 5 research objectives: including evaluating the effect of JT001 (VV116) compared with Paxlovid on the clinical status of the overall subjects; evaluating the safety profile of JT001 (VV116) compared with Paxlovid; evaluating JT001 (VV116) compared with Paxlovid.
    28-day COVID-19 clinical changes; JT001 (VV116) compared to Paxlovid for changes in SARS-CoV-2 by day 14; JT001 (VV116) compared to Paxlovid for changes in chest CT scans up to day 10
    .

    The primary endpoints of the clinical trial were time to sustained clinical recovery (by Day 28) and the percentage of subjects who developed COVID-19 progression (defined as progression to severe/critical COVID-19 or death from any cause) by Day 28
    .

    Some people in the industry said that considering that Paxlovid is currently the most promising oral antiviral drug for the new coronavirus in the world, VV116 chooses to directly compare it with it.
    Once it shows superior or even non-inferior efficacy, it will bring great market prospects to VV116.
    help
    .

      Three Phase I clinical data of VV116 have been announced At present, there are many studies on the effect of VV116 in the treatment of new crowns being carried out at home and abroad.
    In March this year, Junshi Biosciences announced three Phase I clinical data on VV116
    .

    According to the announcement of Junshi Biology, the results of the above three clinical studies show that VV116 is rapidly absorbed orally; repeated administration can maintain effective antiviral concentration; ordinary diet has no effect on VV116 drug exposure.
    In terms of safety, VV116 is used in healthy subjects showed satisfactory safety and tolerability
    .

    None of the three studies reported death, serious adverse events (SAEs), grade 3 or higher adverse events (AEs), or adverse events leading to discontinuation or discontinuation of treatment
    .

    All adverse events recovered without treatment or intervention
    .

    Compared with previously reported data for similar drugs, VV116 has a lower risk of hepatotoxicity
    .

    Based on the positive results of the above Phase I study, Junshi Biosciences and Wangshan Wangshui have initiated an international multicenter, double-blind, randomized, placebo-controlled, Phase II/III clinical study (NCT05242042) for mild to moderate COVID-19 patients.
    19 patients
    .

    The study, co-chaired by Professor Zhang Wenhong of Huashan Hospital Affiliated to Fudan University and Professor Shen Yinzhong of Shanghai Public Health Clinical Center, aimed to evaluate the efficacy, safety and pharmacokinetics of VV116 for early treatment of mild to moderate COVID-19 patients
    .

    At the same time, another international multicenter, randomized, double-blind, controlled phase III clinical study evaluating the efficacy and safety of VV116 compared with standard treatment in subjects with moderate to severe COVID-19 is also underway
    .

    In addition, Nature's journal "Signal Transduction and Targeted Therapy" recently published online the results of a preclinical in vivo efficacy study of VV116 as a potential respiratory syncytial virus (RSV) inhibitor
    .

    The study found that VV116 has excellent antiviral effect on multiple sensitive cell lines of RSV
    .

    In the mouse model, VV116 has high oral bioavailability, good tissue distribution and significantly better antiviral effect than ribavirin, and can alleviate the pathological damage of lung tissue, Junshi said, This study provides a valuable clinical candidate for the treatment of RSV infection
    .

      Paxlovid Phase 2/3 clinical data showed an 89.
    1% reduction in the risk of death Recently, a Phase 2/3 clinical data on Paxlovid was also officially published in the New England Journal of Medicine
    .

    A total of 2,102 patients participated in and completed the study in this Phase 2/3 clinical study.
    They were randomized 1:1 to receive Paxlovid or placebo every 12 hours for 5 days (10 doses in total)
    .

    Results from this phase 2-3 trial in unvaccinated individuals demonstrated the efficacy of nirmatrelvir (300 mg) versus ritonavir (100 mg) administered orally every 12 hours for 5 days
    .

    In the analysis, this regimen was found to reduce the relative risk of COVID-19-related hospitalization or day 28 death from any cause by 89.
    1% in non-hospitalized adults at high risk for progression to severe disease
    .

    Relative risk reductions of 88.
    9% and 87.
    8% were observed in patients who started treatment within 3 and 5 days of symptom onset, respectively, with 0 deaths in the Paxlovid group and 13 deaths in the placebo group
    .

    This efficacy was supported by a subgroup analysis of the primary endpoint; regardless of age, sex, race, BMI, baseline serological status, viral load, Paxlovid-treated patients either had no COVID-19-related hospitalization or all-cause death, or Risk was significantly lower than placebo, comorbidity, or the number of comorbidities at baseline
    .

    Paxlovid treatment was also associated with an additional 10-fold reduction in SARS-CoV-2 viral load on day 5 compared to placebo
    .

    Article | Medical Valley Disclaimer The articles reproduced by the "Yaodu" public account are from other public account platforms, and the main purpose is to share industry-related knowledge and transmit the latest information
    .

    The copyrights of pictures and articles belong to the original authors.
    If there is any infringement, please inform us in time, and we will delete the relevant information within 24 hours.

    .


    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.