Oral COVID-19 Vaccine Candidate Launches Phase 2 Study

California-based Vaxart, Inc. announced that it has begun recruiting subjects for its Phase II COVID-19 oral tablet vaccine candidate clinical trial. The Company stated in a press release it expects to start dosing the first of 96 U.S. subjects with VXA-CoV2-1.1-S, split evenly between COVID-19 naïve and mRNA vaccinated subjects, later in October 2021

The Phase II COVID-19 program will also include countries outside of the United States, starting with a trial in India that is expected to begin later in 2021.

• Part 1: An open-label, dose, and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.
• Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring seven days after the second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. The vaccine candidate's safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.

"Phase II is an extremely important milestone in the development of the first and only COVID-19 oral tablet vaccine that has reached this phase of development," stated Vaxart CEO Andrei Floroiu on October 6, 2021. 

"An oral vaccine has the potential to dramatically impact the world's response to the COVID-19 pandemic and to improve global public health."

"It can be easier and faster to administer than injectables and can help mitigate vaccine hesitancy, as many of those unwilling to get vaccinated by needle would take an oral tablet vaccine," Floroiu added.

On August 2, 2021, the Company confirmed the U.S. FDA had cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate.

"We're very excited to start Phase II trials of our S-only vaccine candidate because, in our nonhuman primate studies, our S-only vaccine produced much higher serum antibody levels than the S+N construct did," commented Dr. Sean Tucker, Vaxart's founder and Chief Scientific Officer. 

"Vaxart's new trials will generate key data that will allow us to compare the S-only and S+N vaccine candidates and help us decide on the best development path forward for our COVID-19 vaccine program, particularly in the face of emerging variant strains," added Dr. Tucker.

Vaxart is a clinical-stage biotechnology company based in South San Fransico, CA, developing a range of oral recombinant vaccines based on its proprietary delivery platform. The Company's overview presentation was published in September 2021.