Vaxart, Inc., a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced that the U.S. 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.

“Our goal is to deliver the best, most elegant solution for conferring mass protection against COVID-19. Our oral tablet vaccine offers a much more attractive mode of administration than injectables and may confer superior protection against COVID-19 due to activation of mucosal immunity. Importantly, our room-temperature stable tablet is significantly easier and cheaper to store and distribute to the farthest corners of the US and the globe, as it does not require the very costly and complex refrigerated cold chain needed for injectable vaccines.,” said Andrei Floroiu, chief executive officer of Vaxart.

“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.”

COVID-19 Program Updates:

IND Clearance for Phase 1 Clinical Trial Evaluating Oral COVID-19 Vaccine
The Phase 1, open-label, 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.

Data from Two Ongoing Animal Challenge Studies expected starting with mid-October
Vaxart is 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.

In addition, and as previously disclosed, 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.

Sean Tucker Ph.D., the chief scientific officer added, “In addition to our clinical program progress, we have a hamster challenge study underway with our COVID-19 vaccine candidate to assess the potential contribution of inducing mucosal immunity to overall efficacy. We are also awaiting the results from a non-human primate study. Both hamsters and monkeys are susceptible to SARS-CoV-2 infection and these models may be capable of providing a deeper understanding of the immune responses and correlate of protection elicited by our oral vaccine candidate.”