LOUISVILLE, Ky. — The University of Louisville (UofL) will soon develop and test a nasal spray that prevents viral respiratory infections like COVID-19, according to a multi-million dollar agreement with the U.S. Department of Defense (DoD).

The one-year project — funded by $8.5 million provided by the DoD — includes developing the spray, testing the formulation, and conducting a Phase I clinical trial. The spray will utilize Q-Griffithsin, a drug compound developed and co-owned by UofL.

If positive results come out of the clinical trials, researchers would seek U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for deployment, a step that the researchers said could happen as soon as the end of 2021.

Kenneth E. Palmer, director of the UofL Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases, is leading the project, formally known as “PREVENT-CoV.”

Researchers expect the spray to be used primarily to protect health care workers, other essential workers, and vulnerable populations who might not be fully protected by a vaccine.

“The idea is to deliver the antiviral agent to the location in the body where the virus is known to replicate first, the upper respiratory tract,” Palmer said.

Q-Griffithsin (Q-GRFT), an analog of the biologic griffithsin, is a potent antiviral protein that acts against multiple coronaviruses, including MERS, SARS-CoV and SARS-CoV-2.

Joshua Fuqua, a professor in the UofL Department of Pharmacology and Toxicology, said an application using Q-GRFT to prevent HIV infection is already in its Phase I clinical trial.

“The relatively short time frame for this project is possible due to the fact that we have a supply of Q-GRFT on hand and that it already has undergone testing related to the HIV preventative,” Fuqua said.

UofL researchers will develop and manufacture the nasal spray, to be used once a day to prevent SARS-CoV-2 (COVID-19) infection, in partnership with several doctors from the University of Pittsburgh, the National Cancer Institute, and the Magee-Womens Research Institute.

Following development and testing, the UofL Clinical Trials Unit will conduct a Phase I clinical trial to test the spray in healthy volunteers in a “controlled, randomized study to evaluate its safety, ease of use, drug activity and tolerability.”

“We are pleased to work with the University of Louisville and hopeful about the prospect of developing Q-Griffithsin to combat COVID-19,” said Douglas Bryce, the DoD’s joint program executive officer for chemical, biological, radiological and nuclear defense. “Repurposing a medical countermeasure that is already in development as a stopgap to potentially provide pre-exposure prophylaxis is a critical component of an effective layered defense.”

“Pursuing innovative solutions with our partners supports both our service members and the American public as we continue our fight against this and other diseases."

Bryce Shreve is a digital producer with Spectrum News 1 KY. He is a recent graduate of Indiana University Southeast and joined the staff in November, 2020.