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Vaxart on go with human trials of COVID-19 vaccine candidate

September 14, 2020

Vaxart (NASDAQ:VXRT) jumps 16% premarket after the FDA completed review of its Investigational New Drug (IND) application for Phase 1 clinical trial evaluating the Company’s oral COVID-19 vaccine candidate. VXRT also provided an update on its COVID-19 program.

“The IND clearance and the initiation of our Phase 1 clinical trial moves us a step closer to proving the superiority of our convenient oral COVID-19 solution in the clinic. We are thus excited to start enrollment for our Phase 1 this month,” said Andrei Floroiu, CEO.

The Phase 1, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine.

Secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19.

Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to provide efficacy data and insights into the optimal dose regimen.  Results from this study are expected mid-October.

In addition, 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.

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