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Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea
Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Published by Elsevier Ltd.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9829441/ https://www.ncbi.nlm.nih.gov/pubmed/36634813 http://dx.doi.org/10.1016/j.pupt.2023.102189 |
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author | Noh, Hyuna Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung |
author_facet | Noh, Hyuna Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung |
author_sort | Noh, Hyuna |
collection | PubMed |
description | Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. |
format | Online Article Text |
id | pubmed-9829441 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Published by Elsevier Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-98294412023-01-10 Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea Noh, Hyuna Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung Pulm Pharmacol Ther Article Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and therapeutics for SARS-CoV-2. The project proceeded as follows: 1) evaluation system setup (including Animal Biosafety Level 3 (ABSL3) facility alliance, standardized nonclinical evaluation protocol, and laboratory information management system), 2) application (including committee review and selection), and 3) evaluation (including expert judgment and reporting). After receiving 101 applications, the selection committee reviewed pharmacokinetics, toxicity, and efficacy data and selected 32 final candidates. In the nonclinical efficacy test, we used golden Syrian hamsters and human angiotensin-converting enzyme 2 transgenic mice under a cytokeratin 18 promoter to evaluate mortality, clinical signs, body weight, viral titer, neutralizing antibody presence, and histopathology. These data indicated eight new drugs and one repositioned drug having significant efficacy for COVID-19. Three vaccine and four antiviral drugs exerted significant protective activities against SARS-CoV-2 pathogenesis. Additionally, two anti-inflammatory drugs showed therapeutic effects on lung lesions and weight loss through their mechanism of action but did not affect viral replication. Along with systematic verification of COVID-19 animal models through large-scale studies, our findings suggest that ABSL3 multicenter alliance and nonclinical evaluation protocol standardization can promote reliable efficacy testing against COVID-19, thus expediting medical product development. Published by Elsevier Ltd. 2023-06 2023-01-10 /pmc/articles/PMC9829441/ /pubmed/36634813 http://dx.doi.org/10.1016/j.pupt.2023.102189 Text en © 2023 Published by Elsevier Ltd. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Article Noh, Hyuna Yoon, Suhyeon Kim, Sung-Hee Kim, Jiseon Seo, Jung Seon Kim, Jeong Jin Park, In Ho Oh, Jooyeon Bae, Joon-Yong Lee, Gee Eun Woo, Sun-Je Seo, Sun-Min Kim, Na-Won Lee, Youn Woo Jang, Hui Jeong Hong, Seung-Min An, Se-Hee Lyoo, Kwang-Soo Yeom, Minjoo Lee, Hanbyeul Jung, Bud Yoon, Sun-Woo Kang, Jung-Ah Seok, Sang-Hyuk Lee, Yu Jin Kim, Seo Yeon Kim, Young Been Hwang, Ji-Yeon On, Dain Lim, Soo-Yeon Kim, Sol Pin Jang, Ji Yun Lee, Ho Kim, Kyoungmi Lee, Hyo-Jung Kim, Hong Bin Kim, Sun Bean Park, Jun Won Jeong, Dae Gwin Song, Daesub Choi, Kang-Seuk Lee, Ho-Young Choi, Yang-Kyu Choi, Jung-ah Song, Manki Park, Man-Seong Seo, Jun-Young Shin, Jeon-Soo Yun, Jun-Won Nam, Ki Taek Seong, Je Kyung Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title | Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title_full | Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title_fullStr | Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title_full_unstemmed | Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title_short | Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea |
title_sort | establishment of multicenter covid-19 therapeutics preclinical test system in republic of korea |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9829441/ https://www.ncbi.nlm.nih.gov/pubmed/36634813 http://dx.doi.org/10.1016/j.pupt.2023.102189 |
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