Ensysce Biosciences, a California-based company that produces pharmaceuticals, is taking steps toward a clinical trial of an ingredient used in its opioid overdose protection products as a treatment for COVID-19.
The ingredient, the oral Nafamostat, is a synthetic protease inhibitor and would be tested to see if it would be effective in preventing or reducing the lethal outcome of COVID-19 infection.
Several studies concluded that Nafamostat is an inhibitor that blocks viral entry into host cells. It has been studied regarding Middle East Respiratory Syndrome and SARS-CoV-2. Ensysce is reviewing its data from a prior clinical trial in Australia that evaluated nafamostat orally.
“We are committed to getting this oral study running as fast as possible,” Dr. Lynn Kirkpatrick, Ensysce Biosciences CEO, said. “We have previously shown that Nafamostat can be safely administered orally to healthy subjects, and this data allows us to explore the beneficial effects of Nafamostat in those individuals who are experiencing symptoms related to COVID-19. We are very happy to be able to work with international medical sites to quickly initiate this potentially lifesaving study and are keen to start a similar trial in the US as soon as possible.”
The company has requested emergency use authorization from the U.S. Food and Drug Administration to start a trial in the United States and is seeking clinical sites.