NRx Pharmaceuticals has launched a Phase IIb dose-confirmatory clinical trial of the Covid-19 vaccine, BriLife, in the nation of Georgia.
Developed by the Israel Institute for Biological Research (IIBR), the self-propagating, live-virus vaccine presents the entire SARS-CoV-2 spike protein to the immune system of the body.
Upon discovery of new SARS-CoV-2 variants, the spike protein complex from such variants can be added to update the vaccine.
Last month, NRx entered a memorandum of understanding with the Israeli Government to license exclusive global development, manufacturing and commercialisation rights to BriLife.
The Phase IIb trial is being carried out under the guidance of Senator Richard Lugar Center for Public Health Research in Georgia.
It will analyse the ability of the vaccine to induce an immune response against the Covid-19 Delta variant, before advancing into Phase III trials in various countries.
In addition, the Phase IIb programme will include a potential intradermal inoculation option, where the vaccine is administered into the skin rather than the standard needle injection into a muscle.
NRx Pharmaceuticals CEO and chairman professor Jonathan Javitt said: “We at NRx are honoured to have been selected for this project and grateful for the trust placed in us by the Government of Israel, the people of Georgia, and its neighbouring countries.
“As the Delta and subsequent variants continue to threaten the immunity generated by first-generation vaccines, we hope that this new vector-based approach may offer enhanced immunity.”
The trials in Georgia will be conducted in parallel with the conclusion of the Phase II trials in Israel.
Furthermore, the company is currently enrolling subjects and extending the Phase II trials globally to boost the statistical sample and prepare the regulatory file needed for trials in the future.
An Israel Minister of Defense spokesperson said: “IIBR will accompany the process and will continue to provide scientific knowledge in order to complete the trials.”