Vaxart (NASDAQ:VXRT) moved one step closer to producing clinical trial data for its oral coronavirus vaccine. The Food and Drug Administration (FDA) cleared the investigational new drug (IND) application for a phase 1 clinical trial. The FDA reviews INDs to make sure there aren't any safety concerns in the preclinical animal data before allowing companies to start clinical trials.
The study, which is scheduled to start enrolling patients later this month, will test two doses of the vaccine in adults ages 18 to 55. The company didn't say how many participants it plans to enroll nor how far apart the doses will be given.
As an early stage study, the primary objective is to check for safety, but Vaxart also plans to look at the immune response, such as the creation of antibodies against the novel coronavirus, and even whether the participants develop COVID-19, the disease caused by the novel coronavirus.
Before there's efficacy data in humans, investors will get to see whether the vaccine can protect hamsters from getting COVID-19. Unlike humans, for which researchers have to count on accidental exposure, the hamster studies will have the animals purposely exposed to the novel coronavirus to see if the vaccination protects the animals. Results from the study are expected in mid-October.
Vaxart is part of Operation Warp Speed, so the vaccine is also being tested in a challenge study in non-human primates that will compare various coronavirus vaccine candidates head to head.
Vaxart is substantially behind other drugmakers, which are already in phase 3 development for their coronavirus vaccines. But Vaxart's oral tablets that are stable at room temperate have huge benefits over the current front-runners, which need to be injected and stored frozen.