Biotechnology firm Vaxart has received clearance from the US Food and Drug Administration (FDA) to conduct a Phase I clinical trial of its Covid-19 vaccine candidate.
The company is developing an oral vaccine to prevent Covid-19. Based on the company’s oral tablet vaccine platform, the candidate is expected to elicit mucosal and systemic immune responses.
Vaxart submitted an investigational new drug (IND) application last month seeking approval for a Phase I trial of the vaccine candidate.
The open-label, dose-ranging trial will be performed in healthy adults aged 18 to 55 years. Enrolment for the study is expected to begin this month.
Primary objective is to assess the safety and reactogenicity of two-doses of the vaccine candidate, while secondary objectives include immunogenicity, immune response duration and occurrence of symptomatic Covid-19.
Vaxart CEO Andrei Floroiu said: “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.
“The IND clearance and the initiation of our Phase I clinical trial moves us a step closer to proving the superiority of our convenient oral Covid-19 solution in the clinic.”
Last month, the company started a SARS-CoV-2 challenge study in hamsters to capture efficacy data and insights into the optimal dose regimen of the Covid-19 vaccine candidate. Results are set to be reported next month.
The company will also report data from a non-human primate (NHP) challenge study, which is being conducted in a harmonized protocol under the US Government’s Operation Warp Speed programme.
Vaxart is performing this preclinical programme in alliance with the Biomedical Advanced Research and Development Authority (BARDA) and other entities that are part of Operation Warp Speed.
Vaxart chief scientific officer Sean Tucker said: “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 correlates of protection elicited by our oral vaccine candidate.”
The company expects that its room-temperature stable vaccine tablet will be easier and cheaper to store and distribute in the US and other international markets.