Vaxart Begins Recruiting in Global Phase II COVID-19 Oral Tablet Vaccine Clinical Trial
- Category: Vaccines
- Published on Wednesday, 06 October 2021 17:08
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Start of US Phase II of S-Only Vaccine Candidate Expected Later This Month
Ex-US Clinical Trials to Begin Later This Year with India Study
SOUTH SAN FRANCISCO, CA, USA I October 6, 2021 I Vaxart, Inc. (NASDAQ: VXRT) today announced that it has begun recruiting subjects for its Phase II COVID-19 oral tablet vaccine clinical trial.
Vaxart expects to begin dosing the first of 96 U.S. subjects, split evenly between COVID-19 naïve and mRNA vaccinated subjects, later this month.
The company's 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 this year.
"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," said Vaxart Chief Executive Officer, Andrei Floroiu.
"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 said.
"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," said 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 developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart's development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.