Establishment of multicenter COVID-19 therapeutics preclinical test system in Republic of Korea.

Hyuna Noh,Suhyeon Yoon,Sung-Hee Kim,Jiseon Kim,Jung Seon Seo,Jeong Jin Kim,In Ho Park,Jooyeon Oh,Joon-Yong Bae,Gee Eun Lee,Sun-Je Woo,Sun-Min Seo,Na-Won Kim,Youn Woo Lee,Hui Jeong Jang,Seung-Min Hong,Se-Hee An,Kwang-Soo Lyoo,Minjoo Yeom,Hanbyeul Lee, Bud Jung, Sun-Woo Yoon, Jung-Ah Kang, Sang-Hyuk Seok, Yu Jin Lee, Seo Yeon Kim, Young Been Kim, Ji-Yeon Hwang, Dain On, Soo-Yeon Lim, Sol Pin Kim, Ji Yun Jang,Ho Lee, Kyoungmi Kim, Hyo-Jung Lee,Hong Bin Kim, Sun Bean Kim, Jun Won Park, Dae Gwin Jeong,Daesub Song, Kang-Seuk Choi, Ho-Young Lee, Yang-Kyu Choi, Jung-Ah Choi, Manki Song, Man-Seong Park, Jun-Young Seo, Jeon-Soo Shin, Jun-Won Yun, Ki Taek Nam,Je Kyung Seong

Pulmonary pharmacology & therapeutics(2023)

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摘要
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.
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