9 Dec. 2020. A group of university and government labs is formulating an antiviral drug as a nasal spray for use as a daily preventive vaccine against Covid-19 infections. The one-year project is led by researchers at University of Louisville in Kentucky and funded by an $8.5 million grant from Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, or JPEO-CBRND.
The team led by Louisville’s Kenneth Palmer, director of the university’s Center for Predictive Medicine, is reformulating the current drug Q-Griffithsin, an analog of the natural biologic griffithsin, derived from red algae. Griffithsin is made from lectin proteins in algae that bind to carbohydrate molecules on the surfaces of viruses, with minimal toxicity to host cells. Q-Griffithsin is a synthetic form of griffithsin, first developed as a preventive agent against HIV infection. An early-stage clinical trial begun in July 2019 is testing Q-Griffithsin in enema form to prevent HIV infections.
Q-Griffithsin is a discovery of National Cancer Institute at National Institutes of Health, with ownership rights shared with Universities of Louisville and Pittsburgh, who are all part of the project to create a protective nasal spray against Covid-19. This daily nasal spray is expected to protect health care workers, and other essential workers including military personnel, working in close quarters, as well as more vulnerable people needing extra protection.
“The idea,” says Palmer in a University of Louisville statement, “is to deliver the antiviral agent to the location in the body where the virus is known to replicate first, the upper respiratory tract.”
Since Q-Griffithsin, or Q-GRFT, is already being evaluated in a clinical trial for HIV, work on a nasal spray formulation can be squeezed into one year. “The relatively short timeframe for this project,” says Joshua Fuqua, a Louisville pharmacology faculty member and the project’s day-to-day manager, “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.”
Douglas Bryce, executive officer for JPEO-CBRND, the funding agency, adds, “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.”
The project team plans to devise a nasal spray form of Q-Griffithsin, and will test the spray with human tissue samples in the lab as well as lab animals. The project also expects to begin a clinical trial recruiting volunteers to test the vaccine for adverse effects, tolerability, ease of use, and chemical activity in the body. If results show the nasal spray is safe and effective, the researchers will ask the Food and Drug Administration for an emergency use authorization for its deployment.
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