Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea
- Authors
- 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
- Issue Date
- Jun-2023
- Publisher
- Academic Press
- Keywords
- SARS-CoV-2; COVID-19; Nonclinical; hACE2 mouse; Golden Syrian hamster
- Citation
- Pulmonary Pharmacology and Therapeutics, v.80
- Indexed
- SCIE
SCOPUS
- Journal Title
- Pulmonary Pharmacology and Therapeutics
- Volume
- 80
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/63362
- DOI
- 10.1016/j.pupt.2023.102189
- ISSN
- 1094-5539
1522-9629
- Abstract
- Throughout the recent COVID-19 pandemic, South Korea led national efforts to develop vaccines and thera-peutics 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 infor-mation 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 veri-fication 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.
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- Appears in
Collections - 1. Basic Science > Department of Microbiology > 1. Journal Articles
- 2. Clinical Science > Department of Infectious Diseases > 1. Journal Articles
- 1. Basic Science > Department of Physiology > 1. Journal Articles
- 4. Research institute > Institute for Viral Diseases > 1. Journal Articles
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