COVID-19: Identification and Development of Clinical Candidates to Treat SARS-CoV-2

TDB已经进行了一系列重新筛选工作，并在ind指导下开发了GS-441524。后者包括药物代谢和药代动力学（PK）研究，人体PK模型，毒理学研究，药品生产和配方研究。TDB科学家还向开放数据门户提供数据和协议，该门户是由NCATS创建的资源，用于存储在NCATS进行的sars - cov -2相关分析产生的数据集。这项工作将COVID-19相关数据存储在一个开放的数据共享平台上，使研究科学家、临床研究人员和公共卫生官员能够优先考虑有前途的化合物和再利用药物，以进一步开发治疗COVID-19的药物

TDB has performed a number of repurposing screening efforts and the IND-directed development of GS-441524. The latter included drug metabolism and pharmacokinetic (PK) studies, human PK modeling, toxicology studies, drug product manufacture and formulation studies. TDB scientists are also contributing data and protocols to the Open Data Portal, a resource created by NCATS to house a collection of datasets generated from SARS-CoV-2-related assays performed at NCATS. This effort deposits COVID-19 related data in an open data-sharing platform to allow research scientists, clinical investigators and public health officials to prioritize promising compounds and repurposed drugs for further development in treating COVID-19 As part of the broader public health response to COVID-19, TDB scientists have participated in the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, using SARS-CoV-2 pseudotyped particle (PP) entry assays to test the efficacies of vaccinated human sera against emerging SARS-CoV-2 spike protein variants. The surveillance of variant mutations and their impact on COVID-19 vaccines is a critical task that involves multiple government organizations. TDB scientists employed the PP entry assay to test the neutralization potency of SARS-CoV-2 vaccinated sera, including homologous and heterologous boosted sera, against more than 18 SARS-CoV-2 variants, including delta, omicron, and omicron subvariants. All the data have been quickly and openly disseminated using the NCATS OpenData Portal. This work has provided the NIH leadership, industry, academic partners, and the external research community with a comprehensive, standardized assessment of how current vaccines are impacted by emerging SARS-CoV-2 variants.