On December 29, 2022, the global authoritative journal “The Newland Journal of Medicine (NEJM, influence: 176.079) published online publishing the oral nucleoside anti-new coronary virus (SARS-COV-2) Pharmaceutical VV116 (JT001) Compared with the Narmatvir tablet/Litonovid Pharmaceutical (PaxLovid), it is used to accompany the progressive progress of the high-risk factors including death (COVID-COVID-19) The results of Phase III clinical research (NCT05341609) for patients with early treatment.This is the first clinical trial of New Crown Innovation Pharmaceuticals developed by Nejm.
The study was led by Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine. It was the first time for the “head opposite” clinical research of small molecules oral antiviral drugs to the Chinese COVID-19 patients during the popularity of Omikon.The results show that the main endpoint of the study reaches the non -inferior endpoint of design. Compared with the PAXLOVID, the clinical recovery time of the VV116 group is shorter and the safety of safety is less.
Post a screenshot, source: nejm official website
Published by Professor Zhao Ren, Affiliated to Shanghai Jiaotong University School of Medicine, Professor Renji Hospital of Shanghai Jiaotong University School of Medicine, Professor Renji Hospital, Academician Ning Guang, Professor Xu Yiping, and Professor Xie Qing of Shanghai Jiaotong University School of Medicine CollegeThe author, Cao Zhujun, Gao Weiyi, Gao Weiyi, Pudong Hospital affiliated to Fudan University, Feng Haiyan, Feng Haiyan, Shanghai Public Health Clinical Center, and Mei Shuya, a Shanghai Jiaotong University School of Medicine, as the first author.
Professor Zhao Ren said: “Thanks to patients and research teams for their support, let us complete this clinical study high -quality, and have been published in the top international journal” New England Medical Magazine “. The research and development and clinical applications of the two mainstream development routes ‘RDRP inhibitors’ and ‘3CL protease inhibitors’ provides valuable data and experience, and also shows the efficacy and safety of anti -new crown oral drugs independently developed by my country. Looking forward to our research results can contribute and wisdom to my country’s resistance work! “
Dr. Zou Jianjun, president of Junshi Bio Global R & D, said: “At present, the epidemic prevention and control is still full of challenges, especially patients with patients with severe high -risk factors. Study in the publication of Nejm proves the clinical development of drugs in the international academic community on Chinese experts and Chinese pharmaceutical companies, whether it is test design, test quality, or experimental results, we are highly recognized. We are continuously investing VV116 The clinical development of indications in other people hopes to provide better and safer treatment options for new patients in my country and the world! “
At present, the new crown epidemic is still continuously spread globally, and the ability to spread and escape from viruses continues to increase with mutation.Oral antiviral drugs have the advantages of having convenience for administration, high drug resistance, and low transportation storage restrictions, which will help alleviate the medical burden of medical care.However, at present, there are still many factors that lead to limited application of drugs (such as: the interaction, availability of drugs and drugs, etc.), so it is necessary to develop more effective and safe treatment of drugs.
VV116 is an oral nucleoside antiviral drug independently developed by my country, which can inhibit SARS-COV-2 replication.Pre -clinical studies have shown that VV116 shows a significant antiviral effect on the primitive strains and known mutation plants in the new crown virus, and shows satisfactory safety, tolerance and pharmaceutical dynamic properties in phase I clinical studies.EssenceA preliminary small-scale study confirmed that compared with conventional treatment, the nucleic acid to patients who received VV116 treatment within 5 days after the SARS-COV-2 test for the first time after the first test of SARS-COV-2 was shorter.
This time it was published as a multi -center, single -blindness (researcher maintained blind state), random, and controlling phase III clinical trial (NCT05341609). From April 4 to May 2, 2022, 7 new crowns in ShanghaiPnega-point hospitals were jointly carried out and were included in 822 cases of adult patients with high risks with high risks. They were allocated to VV116 and the PAXLOVID group at a ratio of 1: 1.In the end, a total of 771 patients (full analysis, FAS) patients received the treatment of VV116 (n = 384) or Paxlovid (n = 387).
Among them, the median age of FAS patients is 53 years (scope: 18 ~ 94), female accounts for 50.2%, mild patients account for 92.1%, 75.7%of patients have vaccinated new crown vaccines or enhanced needles, 77.3%of 77.3%Patients received VV116 or Paxlovid treatment within 5 days of symptoms.The most common high -risk factors among patients include: age ≥60 years (37.7%), cardiovascular disease (including high blood pressure) (35.1%), obesity or overweight BMI ≥ 25 (32.9%), current smoking (12.5%) andDiabetes (10.1%).The main ending of the study is from random to continuous clinical recovery. The risk ratio (HR) on both sides of (HR) is defined as non -inferiority.The endpoint of the secondary efficacy includes the proportion of severe/dangerous COVID-19 or patients with severe due to death, COVID-19 related symptom scores and WHO clinical progress scores, time to disappear symptoms, SARS-COV-2 nucleic acid negative time, etc.The endpoint of security includes adverse events (AE) and severe adverse events (SAE).
According to the final analysis results (as of August 18, 2022), among the FAS crowd, VV116 and Paxlovid reached non -inferiority in the “continuous clinical recovery time” (HR = 1.17, 95%CI: 1.02 ~ 1.36), andVv116 group recovery time is shorter than the mid -position recovery time of the PAXLODID group (4 days VS. 5 days).
The final analysis results of the continuous clinical recovery time of the FAS crowd
The VV116 group and the PaxLovid group performed similarly in the “time to the disappearance of continuous symptoms” and “the first SARS-COV-2 nucleic acid negative time”, with a median time of 7 days.At each preset time (5, 7, 10, 14, 28 days), the proportion of patients with alleviating symptoms of VV116 is higher than the PAXLOVID group.None of the two groups of patients made progress in severe/critical COVID-19 or death.
In addition, about 3/4 patients in this study have vaccinated the new crown vaccine, and such patients will be excluded in most studies. The results of the Asian group analysis show that VV116 and PaxLovid areThere is no statistical difference in the treatment results.
In terms of security, VV116 has less security concerns than PaxLovid.The incidence of AE in the VV116 group is lower than the PAXLOVID group (all levels of AE: 67.4% vs. 77.3%, and level 3 or 4 AE: 2.6% vs. 5.7%).It is worth noting that PaxLovid interacts with a variety of drugs (DRUG-DRUG Interaction), while VV116 does not inhibit or induce major drug metabolic enzymes, or inhibit the main drug transfer protein, so the possibility of interaction with consolidated medication is small.