COVISTAT Inc. and its parent company Ensysce Biosciences Inc., received IND allowance and today initiated a Phase 1 clinical trial of oral nafamostat in healthy volunteers. Nafamostat, an ultra-potent protease inhibitor and an ingredient from Ensysce’s opioid overdose protection platform, is being developed as an oral treatment for COVID-19. The ultimate goal will be to evaluate if nafamostat mesylate (nafamostat), that has been shown to be an inhibitor of SARS-CoV-2 host cell entry through TMPRSS2, will be effective in preventing progression to acute respiratory failure, to due to COVID-19 infection.
Nafamostat has been approved for intravenous use in Japan for pancreatitis and other diseases, signifying assurance in the drug’s safety but has never been approved in the USA. Nafamostat has a novel mechanism of action for treating COVID-19 as a potent protease inhibitor that blocks SARS-CoV-2 viral entry into host cells. Because of this it has antiviral properties against other coronaviruses including the Middle East Respiratory Syndrome (MERS), SARS and now SARS-CoV-2. In addition, nafamostat has anti-inflammatory, anti-coagulant, and mucolytic properties which, in combination, could be vital in helping COVID-19 patients avoid the need for hospitalization.