Positive results of the clinical IIa trial of oral respiratory syncytial virus drug RV521
February 06, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On February 5th, ReViral, a British biotechnology company focused on the development of innovative respiratory syncytial virus (RSV) compounds, announced that the company's placebo-controlled clinical IIa challenge study in healthy adult patients with RSV intranasal infections has been positive. result. The company's test drug, RV521, is an oral RSV fusion inhibitor that achieved all major and minor endpoints compared with placebo, including a significant reduction in viral load, reduced mucus weight, and reduced clinical symptoms.
RSV is a pathogen that infects the human respiratory tract and may cause bronchiolitis and pneumonia. Although most (but not all) healthy people can recover from the virus, they are aggravated and killed after infection in premature infants, people with certain lung diseases, the elderly and immunosuppressed people. The risk will increase.
Dr. John DeVincenzo, professor of pediatrics, microbiology, immunology and biochemistry at the University of Tennessee School of Medicine and director of the Molecular and Viral Diagnostics Laboratory at the Leboher Children's Hospital, said: "Children infected with respiratory syncytial virus, immune function Inferior and elderly people often cause serious illness, and there is still a large lack of clinical treatment needs. Based on the reduction of RSV viral load and clinical symptoms, as well as the safety information observed in adult challenge studies, now It is time to speed up clinical trials in patients with natural infections."
Efficacy evaluation was performed on healthy volunteers who had been confirmed to have RSV infection before treatment. In 66 subjects (RV521 and placebo were randomly assigned 2:1), viral load was rapidly reduced to undetectable levels after receiving RV521 treatment. The mean mucus weight and total symptom day of the RV521 treatment group (daily reports of nasal congestion, cough, sore throat, etc.) were also significantly lower than the control group (P < 0.05).
Safety analysis showed that there were no changes in the safety parameters determined by the laboratory, and adverse events between the two dose groups and the placebo group and between the two doses were also balanced. No serious adverse events related to treatment occurred.
ReViral CEO Eddy Littler said: "RV521 has the best potential for treating RSV, including efficacy, dosage and safety. The company will start a new clinical study in infants and young patients. All of this trial The data will be announced at the American Thoracic Society meeting in San Diego."
The clinical trial IIa, which received positive results this time, was a randomized, double-blind, placebo-controlled study in which healthy adult subjects were vaccinated with respiratory syncytial virus on day 0. When these healthy patients were confirmed to have an infection by nasal irrigation or on the 5th day of the study, whichever comes first, they would receive treatment with RV521 or placebo. RV521 or placebo was taken orally twice daily for 5 consecutive days. Subjects were randomized to receive either RV521 or placebo (2:1) at a dose of 200 mg or 350 mg. After the end of the administration, the subject needs to observe the 12th day and can be discharged on the 12th day.
RV521 is an oral small molecule antiviral fusion inhibitor for the treatment of RSV infection. RV521 blocks RSV replication by inhibiting RSV-F mediated fusion of RSV with host cells. In Phase 1 clinical studies, RV521 showed good exposure characteristics with no serious adverse events (any reported adverse events were low-grade, transient, and did not require a combination). In the toxicity test of adult and juvenile preclinical models, RV521 showed good safety and a greater safety margin than the therapeutic dose. (Sina Pharmaceutical Compilation / David)
Article Reference Source: Positive Results Achieved in ReViral's Phase IIa RSV Challenge Study
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