Home » Junshi’s research on new crown oral drugs has raised questions about the primary and secondary endpoints and the truth of the single-blind design_Clinical_Research_Subjects

Junshi’s research on new crown oral drugs has raised questions about the primary and secondary endpoints and the truth of the single-blind design_Clinical_Research_Subjects

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Junshi’s research on new crown oral drugs has raised questions about the primary and secondary endpoints and the truth of the single-blind design_Clinical_Research_Subjects

Original title: Junshi’s research on new crown oral drugs has raised questions about the primary and secondary endpoints, and the truth of the single-blind design

Economic Observer reporter Qu Yixian On May 25, Junshi Biotech (01877.HK/688180.SH) announced partial data of the new crown oral drug VV116 under investigation, saying that VV116 achieved the primary endpoint and secondary efficacy preset by the program in the Phase III registration clinical study. end. As of the close on May 25, Junshi Bio’s A shares and Hong Kong shares both rose around 4%.

Just late at night on May 23, Junshi Biotech announced that VV116 had reached the primary endpoint preset in the protocol in the registration study, saying that it would communicate with the regulatory authorities to apply for new drug listing in the near future.

However, because the information disclosed in the announcement was too brief, it caused a lot of discussions and questions. On May 24, Junshi Bio’s Hong Kong stock fell by more than 12%, and its A shares fell by 20%.

The primary endpoint and the secondary endpoint, more commonly understood, are equivalent to the primary and secondary indicators observed in clinical trials, and can also be understood as the primary and secondary objectives, respectively.

The above registered clinical study is a multi-center, single-blind, randomized, controlled phase III clinical study, which aims to evaluate the use of VV116 in comparison with Pfizer’s marketed new crown drug nematevir tablets/ritonavir tablets (ie PAXLOVID) for mild to moderate Efficacy and safety of early treatment in patients with severe COVID-19.

It is particularly important to note that VV116 was not compared with placebo in this study, but with the direct “head-to-head” PK efficacy of PAXLOVID, which has been used in many new crown designated hospitals across the country.

Ning Guang, President of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, served as the principal investigator in this study, and 822 patients were actually enrolled. Percentage of subjects with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from all causes) in days” “Time to resolution of persistent clinical symptoms” “Percentage of subjects who converted to SARS-CoV-2 “Wait.

The industry’s most suspicious of VV116 is the primary endpoint. The primary endpoint it sets is “clinical recovery”, while “prevention of severe illness and death” is the secondary endpoint.

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Since the mutation of the new coronavirus, the symptoms caused by the Omikron strain are very mild and rarely infect the lungs. Many infected people quickly “clinically recover” without receiving treatment. Therefore, considering the current reality, reducing the incidence of severe illness and reducing the mortality rate is still one of the most important indicators for considering a candidate new crown drug.

According to the minutes of an exchange meeting of new crown experts at Ruijin Hospital in mid-April, the main endpoint of the original plan was “prevention of severe illness” rather than “clinical recovery”.

A person close to the above-mentioned clinical researcher told Economic Observer.com that regarding the minutes of the meeting transmitted online, after the self-examination of Ruijin Hospital, there were no “experts” who expressed opinions in the minutes.

The Economic Observation Network contacted Chen Peizhan, the registration contact person for the clinical study involved, and asked whether the primary endpoint of the clinical trial plan was changed from “prevention of severe illness” to “clinical recovery”.

A person deeply involved in the research and development of new crown drugs told the Economic Observer.com that under the current epidemic, it is difficult to do a successful Phase III trial. Because most people have been vaccinated, the pathogenicity of the Omicron strain is relatively weak, and the severe rate is very low. It is necessary to make “superior effects” in severe cases and death (note: the effect is better than the control group) or ” Non-inferiority” (note: the effect is not worse than the control group) requires a large sample size.

Junshi Biology stated that the above-mentioned clinical program was carried out after communication with the regulatory authorities. Regarding the primary endpoint, the VV116 group achieved a shorter median time to sustained clinical recovery and achieved statistical superiority, “providing strong evidence that the therapy can accelerate the relief of COVID-19 symptoms.”

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In terms of secondary efficacy endpoints, Junshi Biology stated that neither the VV116 group nor the PAXLOVID group had COVID-19 disease progression or death. At the same time, the results of the study also showed that the time to the disappearance of persistent clinical symptoms and the time to the first SARS-CoV-2 nucleic acid conversion to negative were similar between the two groups. Compared with PAXLOVID, the VV116 group had a statistically superior trend.

In other words, none of the 882 subjects progressed to severe/death in either the experimental or control groups.

2. Whether the single-blind design will interfere with the subjective consciousness of the researcher

In clinical trials, double-blind, in simple terms, means that neither the subjects nor the investigators understand the trial groupings, so the entire trial process can be controlled by the study designer. Correspondingly, single blinding is blinding only one of the subjects and the researcher.

As soon as the announcement was made by Junshi, a voice came out. If the clinical program blinds the subjects, but the researchers know the grouping, will there be too much subjective interference?

Economic Observation Network checked the website of China Clinical Trial Registration Center and found that the research intervention of this clinical trial was blinded to medical staff/researchers. For blinded treatment groups, neither the investigator nor the sponsor study team will know the specific treatment assignment until the final database is locked at the end of the study.

In addition, people close to the above-mentioned clinical researchers pointed out to the Economic Observation Network that because PAXLOVID has a special odor and bitter taste, it cannot be strictly double-blind in clinical trials, and the evaluation researchers are blinded, “Even if there is bias, it is actually It is more favorable for P drug (Note: PAXLOVID).”

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In addition, Junshi Bio said that in terms of safety, VV116 has a good overall safety profile, and the overall adverse event rate is lower than that of PAXLOVID.

Junshi Bio also stated that more detailed research data will be published in academic journals in the future.

According to the website of the China Clinical Trial Registration Center, the specific implementation of the above clinical study is – test group: VV116, the subjects will receive 600 mg of VV116 every 12 hours on the first day, and every 12 hours on the second to fifth days. 300mg of VV116, all of which were taken orally. Control group: Paxlovid, subjects will receive 300mg nelmatevir tablets + 100mg ritonavir tablets orally every 12 hours on days 1-5.

The inclusion criteria for subjects include: subjects must be 18 years of age and older with a positive infection of the new coronavirus; have one or more mild or moderate clinical symptoms of the new coronavirus, such as: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, chills or chills.

At the same time, because it is aimed at patients with mild to moderate new crowns, the subjects need to meet one or more of the following: the first positive new coronavirus infection test sample is ≤7 days after the first administration of the experimental drug; the new coronavirus on the day of the first administration Nucleic acid detection Ct value ≤ 20; the first occurrence of new crown symptoms is ≤ 5 days from the first administration of the experimental drug.

VV116 is currently in an international multi-center Phase III clinical study, and a number of clinical studies on patients with mild to moderate and moderate to severe COVID-19 are underway.

On December 31, 2021, the Ministry of Health of Uzbekistan has granted emergency use authorization for VV116.Return to Sohu, see more

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