logo
Plus   Neg
Share
Email

Vaxart Says FDA Clears IND Application For Oral COVID-19 Vaccine - Quick Facts

Biotechnology company Vaxart, Inc. (VXRT) announced Monday that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. The company also provided an update on its COVID-19 program.

The Phase 1, open-label, dose-ranging clinical trial will be conducted in healthy adults ages 18 to 55 years old. The primary objective is to examine the safety and reactogenicity of two-doses of the vaccine, while the secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.

Vaxart is also conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen of our vaccine candidate. Results from this study, which began in early August, are expected mid-October.

Further, Vaxart is awaiting results from a non-human primate (NHP) challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed. This preclinical program is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and other entities working with Operation Warp Speed.

For comments and feedback contact: editorial@rttnews.com

Follow RTT