Oragenics said that results from a toxicology study of its NT-CoV2-1 intranasal vaccine conducted in rabbits “confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study.” In June 2022, the company published data from preclinical studies of NT-CoV2-1 in mice and hamsters demonstrating that intranasal delivery of the vaccine could induce a strong immune response and reduce viral load in those animals.
Oragenics President and CEO Kim Murphy said, “There is an unmet medical need for an intranasally administered COVID-19 vaccine. We are encouraged by these favorable toxicology study results, which advance the preclinical work required for pursuing regulatory permission to begin human testing. This marks an important milestone in the progress of bringing an intranasal COVID-19 vaccine to the market. Signals of adequate immune responses have been demonstrated in prior preclinical studies with NT-CoV2-1 against multiple SARS-CoV-2 variants of interest. We expect to provide an update on our regulatory pathway in the first quarter of 2023.”
Read the Oragenics press release.