Dec 14, 2020
Department of Defense awards $8.5 million for nasal spray that prevents COVID-19
Formulation, Phase I clinical trial set to begin for spray developed by researchers from Magee and University of Louisville
PITTSBURGH — A nasal spray developed by researchers from the University of Louisville and Magee-Womens Research Institute/the University of Pittsburgh to prevent COVID-19 infection has been awarded a one-year, $8.5 million grant from the U.S. Department of Defense.
The spray is designed to protect users from infection by COVID-19 for at least a day and does not require an immune response for protection, meaning it should still protect people whose immune systems are compromised or those whose immune response is inadequate, according to Dr. Lisa Rohan, Ph.D., an investigator at Magee-Womens Research Institute who is a primary investigator on the project. Dr. Kenneth E. Palmer, Ph.D., leads the project for the University of Louisville.
The nasal spray’s active ingredient is Q-Griffithsin (Q-GRFT), a drug compound derived from algae. The drug was developed and is co-owned by the University of Louisville, the National Cancer Institute (NCI), and the University of Pittsburgh, where Dr. Rohan also serves as a professor in the Department of Pharmaceutical Science at the School of Pharmacy. Q-Griffithsin is already in human clinical trials in a different formulation as a preventative against HIV infection.
Lin Wang, a research scientist in Dr. Rohan’s lab, has led formulation development efforts for the nasal spray.
“This product would not replace a vaccine,” notes Dr. Rohan, but adds that it is valuable for protecting people who are unable to be vaccinated. In addition, the product is designed to be an on-demand, shelf-stable and inexpensive option for prevention.
The Department of Defense grant joins earlier funding for the project from the Richard King Mellon Foundation, Pitt’s Clinical and Translational Science Institute, and Pennsylvania’s Department of Community and Economic Development. Additionally, the National Center for Advancing Translational Sciences has provided support through facilitating the regulatory components of the project to date.
“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,” says Douglas Bryce, the DoD’s joint program executive officer for chemical, biological, radiological and nuclear 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.”
Following the preclinical testing of the nasal spray, a Phase I safety study funded by the NCI will be conducted in Pittsburgh under the direction of Dr. Sharon Hillier, Ph.D., an investigator with Magee-Womens Research Institute. Dr. Rohan estimates these will begin in early April 2021. Additional Phase I clinical trials funded by the DoD will be conducted at the University of Louisville under the direction of Drs. Gerald Dryden and Kevin Potts. Collectively, these studies are designed to evaluate the spray’s safety, ease of use, drug activity and tolerability.
With positive results from these clinical studies, the researchers would seek U.S. Food and Drug Administration Emergency Use Authorization, a step that could happen as soon as the end of 2021.
“The applications of this product are not limited to COVID-19,” adds Dr. Rohan “GRFT has been shown to have activity against other viruses that cause respiratory infection including other coronaviruses and Nipah virus.
“As diseases evolve, this product could be modified to adapt to them and provide protection not just from COVID-19, but from the next global health threat, whenever it appears,” Dr. Rohan added.