Oragenics announced the initiation of a Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits. The study is designed to provide Investigational New Drug (IND)-enabling data to help advance this candidate to human clinical studies. Oragenics has contracted with Frontage Laboratories (through its wholly-owned subsidiary Experimur) to conduct the study, with top-line interim data expected in August.

Glenn Washer, Frontage’s North American President and EVP of Global Safety & Toxicology commented, “We are delighted to support Oragenics on what could be the next generation of vaccines to combat COVID-19 infections. With the recent acquisition of Experimur, Frontage is well positioned to support Oragenics’ development needs through the IND and beyond.”

“We are thrilled to have begun this pivotal study with Frontage, a premier drug development contract research organization, and are thankful to the acceleration Frontage has offered our important IND-enabling study. We believe the results from this rabbit toxicology study will support our development strategy for our intranasal COVID-19 vaccine candidate, NT-CoV2-1. The intranasal delivery route is particularly relevant as it may further reduce transmission of the virus and provide a needle-free delivery option. The findings from this preclinical toxicology study will be a part of our Investigational New Drug filing to the U.S. Food and Drug Administration,” said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.

Oragenics has previously demonstrated protection by NT-CoV2-1 in a hamster challenge study.